[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,79,0,25,[9,55,82,102,134,155,183,203,226,254,264,285,306,332,356,375,402,427,445,464,501,523,551,582,620],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100054010","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100054010",false,"NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.","ALL","65 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[27,28,29,30,31,32],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[34,35,36,37,38,39,40,41],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","NOT_YET_RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":21},"2026-10-31",{"date":50,"type":21},"2030-06-01",{"name":52,"class":53},"University of Arizona","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100053356","phase-2-myelomatch-a-screening-study-to-assign-people-with-myeloid-cancer-to-a-treatment-study-or-standard-of-care-treatment-within-myelomatch-myelomatch-screening-trial-100053356","NCT05564390","MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)","Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials","Inclusion Criteria:\n\n* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.\n* Participants must be \\>= 18 years of age.\n* Participants must not have received prior anti-cancer therapy for AML or MDS.\n\n  * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.\n  * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g\u002Fm\\^2 of cytarabine, which is allowed for urgent cytoreduction.\n* Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.\n\n  * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.\n* Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy\n\n  * Note: active hormonal therapy is allowed\n* Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.\n* Participants must agree to have translational medicine specimens submitted.\n* Participants must be offered the opportunity to participate in specimen banking.\n\n  * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.","18 Years",{"count":64,"type":21},2000,[66],"PHASE2","This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).",[28,69,70,71,30],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic\u002FMyeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemia, Myelodysplasia-Related","RECRUITING",{"date":45,"type":46},{"date":75,"type":46},"2024-06-18",{"date":77,"type":21},"2029-05-15",{"name":79,"class":80},"National Cancer Institute (NCI)","NIH",348,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":54},"100053521","phase-2-induction-and-consolidation-with-fludarabine-cytarabine-idarubicin-and-venetoclax-for-the-treatment-of-acute-myeloid-leukemia-100053521","NCT07228273","Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia","A Phase II Randomized Clinical Trial of Venetoclax Combined With FLAG IDA Induction and Consolidation Compared to Standard of Care for Newly Diagnosed Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Ability to comprehend the investigational nature of the study and provide written informed consent\n* Age 18 to ≤ 65 years (yrs), at the time of consent\n* All gender identities, races, or ethnicities are eligible\n* Newly documented, previously untreated diagnosis of AML or myelodysplastic syndrome (MDS) with marrow blasts ≥ 10%, in agreement with 2022 European LeukemiaNet criteria (ELN22)\n\n  * Leukapheresis and treatment with cytarabine or hydroxyurea prior to study initiation is permitted for cytoreduction in patients with proliferative disease. NOTE: Treatment with cytarabine is limited to up to 2 grams total at least 14 days prior to starting on protocol defined therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Willingness to undergo hematopoietic stem cell transplant (HSCT)\n* Ability to take medications by mouth or feeding tube\n* Adequate hematologic and organ function\n* Institutional standards, New York Heart Association (NYHA) criteria for cardiac function\n* Calculated creatinine clearance (according to the Cockcroft-Gault equation) \\> 40 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x upper limit of normal (ULN), unless considered due to leukemic involvement\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x ULN, unless considered due to leukemic involvement\n* Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's disease or leukemic involvement\n* Willing and able to\n\n  * Adhere to study schedule of activities and lifestyle restrictions while on treatment;\n  * Provide bone marrow (BM) aspirate and core biopsy samples; AND\n  * Accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequelae, including transfusions\n* Negative pregnancy test within 3 days of start of treatment for persons of childbearing potential (PCBP)\n* Based on animal studies and the known pharmacology of the study drugs, PCBP and sperm-producing participants who are sexually active with a PCBP must comply with study requirements for contraception\n\n  * PCBP (participants and PCBP partners of participants) must agree to use an approved contraception and to refrain from donating \u002F cryopreserving ova from cycle (C) 1 day (D) 1 until 6 months following the last dose of study treatment\n  * Participants who produce viable sperm and who have intercourse with PCBP must agree to use an approved contraception method and to refrain from donating sperm from C1D1 until 3 months following the last dose of study treatment\n\nExclusion Criteria:\n\n* Documented t(15;17) (acute promyelocytic leukemia \\[APL\\]), and\u002For mutation(s) to FLT3 ITD or core binding factor (CBF). Point mutations within the tyrosine kinase domain (FLT3 TKD) are allowed\n* Another active malignancy within the previous 5 years, except treated early stage carcinomas of the skin, or at the investigator's discretion\n* Known, active central nervous system (CNS) involvement with AML\n* Recent and significant medical interventions, such as major surgery within 28 days of start of treatment\n* GVHD or autologous stem cell transplant within 100 days of start of treatment\n* Currently receiving investigational therapy or chemotherapy within 28 days, or 5 half-lives, whichever is longer, with the exception of hydroxyurea or cytarabine for cytoreduction purposes\n* Prior treatment with a BCL 2 inhibitor within 12 months prior to the start of treatment\n* Use of strong or moderate CYP3A4 inducers or inhibitors or P-gp inhibitors within 2 days or 3 half-lives, whichever is longer, prior to start of treatment with venetoclax or at the discretion of the investigator if dose reductions, based on the interaction, have been specified\n* History of allergic response to any of the interventional agents or any excipients in the formulations\n* Inadequate organ function, including the following (or at the discretion of the investigator):\n\n  * History of New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan\n  * Unstable\u002Funcontrolled angina pectoris, history of severe and\u002For uncontrolled ventricular arrhythmias, or history of myocardial infarction within the last 6 months\n  * A white blood cell count (WBC) \\> 25 x 10\\^⁹\u002FL\n* Known dysphagia in the absence of a feeding tube, short-gut syndrome, or other conditions or causes that would affect the ingestion and\u002For gastrointestinal absorption of drugs administered orally\n* Active hepatic disorder or documented positive hepatitis B or C virus (HBV\u002FHCV, respectively) status, except in cases of undetectable HBV\u002FHCV viral load for at least 3 months prior to the start of treatment. (Hepatitis B or C testing is not required for eligibility assessment.)\n* Individuals with positive serology for human immunodeficiency virus (HIV) who are undergoing treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents) are not eligible. If the HIV infection is controlled with another medication type or if an acceptable alternative HIV treatment can be substituted for HAART, enrollment may proceed\n* Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to start of treatment and must be amenable to alternate treatment if current treatment will interact with investigational regimen\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding is not allowed throughout the study for 6 weeks after the last dose of study drug",{"count":90,"type":21},102,[66],"This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.",[28,30],"2026-07-09",{"date":45,"type":46},{"date":97,"type":46},"2025-12-12",{"date":99,"type":21},"2029-08-24",{"name":101,"class":53},"OHSU Knight Cancer Institute",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":17,"minAge":62,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",true,"75 Years",{"count":112,"type":21},46,[24],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[116,117,28,118,119,120,121,122,30,123,124,32],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Chronic Lymphocytic Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelofibrosis","Myeloproliferative Neoplasm","2026-06-30",{"date":127,"type":46},"2026-07-02",{"date":125,"type":46},{"date":130,"type":21},"2028-05-30",{"name":132,"class":53},"City of Hope Medical Center",3,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":110,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":54},"100592645","phase-1-emapalumab-with-post-transplant-cyclophosphamide-tacrolimus-and-mycophenolate-mofetil-for-the-prevention-of-graft-versus-host-disease-after-donor-reduced-intensity-hematopoietic-cell-transplant-100592645","NCT06996119","Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant","Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years and ≤ 75 years\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80% and HCT-comorbidity index (CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in complete remission with bone marrow (BM) blast of \\\u003C 5%. AML must be negative for minimal residual disease (MRD-)\n* Planned to undergo reduced-intensity conditioning (RIC) with either fludarabine\u002Fmelphalan (Flu\u002FMel) or busulfan\u002Ffludarabine (Bu\u002FFlu) regimens prior to an allogeneic HCT using a mobilized peripheral blood stem cell (PBMC) graft from an 8\u002F8 match related\u002Funrelated donor (A, B, C, DR by high resolution typing)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 30 days prior to day 1 of protocol therapy\n* Bazett's correction formula (QTcB) ≤ 480 ms\n* If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* QuantiFERON-TB Gold+\n\n  * Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive purified protein derivative (PPD) test result, or positive interferon gamma (IFNγ) release assay\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 180 days post-HCT\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Other cancer therapies (chemotherapy, radiation, biologics) are not allowed within two weeks of starting HCT conditioning; however targeted agents for underlying hematologic malignancies may be continued up to one day before conditioning, including, but not limited to:\n\n  * FLT3 inhibitors\n  * IDH1\u002F2 inhibitors\n  * Menin inhibitors\n  * ABL-BCR inhibitors\n  * BCL-2 inhibitors\n  * Hydroxyurea\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Psychological issues, no appropriate caregivers identified, or non-compliant to medication\n* Clinically significant uncontrolled illness\n* Active uncontrolled infections (bacterial, viral, fungal). Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, no signs of infection are present\n* Other active malignancy\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":142,"type":21},15,[24],"This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \\[peripheral blood stem cell\\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and\u002For effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.",[28,146,30],"Graft Versus Host Disease","2026-06-29",{"date":149,"type":46},"2026-07-01",{"date":151,"type":46},"2026-06-12",{"date":153,"type":21},"2027-05-25",{"name":132,"class":53},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":54},"100619653","phase-1-cd64-car-t-cell-therapy-in-adults-with-relapsed-andor-refractory-aml-100619653","NCT07347418","CD64 CAR T Cell Therapy in Adults With Relapsed and\u002For Refractory AML","Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety, Expansion, Persistence, and Preliminary Clinical Activity of Autologous CD64 CAR T Cells in Patients With Relapsed and\u002For Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Subjects must have one of the following diagnoses per the International Consensus Classification (ICC) 2022 criteria:\n\n   a. Acute Myeloid Leukemia (AML).\n3. Refractory OR relapsed AML:\n\n   a. Refractory disease i. ≥5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry, or immunohistochemistry after a minimum of 1 cycle of a hypomethylating agent (HMA) and venetoclax (Ven) combination (Ven\u002FHMA) b. Relapsed disease i. Recurrence of ≥ 5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry or immunohistochemistry.\n4. Subjects must have received at least one prior line of therapy, including at least one line of therapy containing Ven.\n5. Documentation of CD64 expression on ≥70% of myeloid blasts by flow cytometry after the most recent relapse, as determined by standardized and validated multiparameter flow cytometry assay (Hematologics, Inc., Seattle, WA).\n6. Total white blood cell (WBC) count ≤ 25 x 10(to the 9th)\u002FL prior to apheresis. Hydroxyurea is permitted to achieve this\n7. Absolute lymphocyte count (ALC) ≥ 200\u002FµL prior to apheresis OR ALC \\\u003C 200 µL with concurrent lymphocyte subset analysis (CD3, CD4, and CD8 counts) confirming an absolute CD3 count ≥ 150\u002FµL.\n8. Confirmed availability of cells for a rescue stem cell transplant AND subject must be deemed an appropriate candidate for such therapy per institutional standards.\n9. Subjects who have undergone prior allogeneic stem cell transplant must be ≥ 6 months out from transplant and be off systemic immunosuppression for at least 1 month at the time of enrollment with no evidence of active graft versus host disease.\n10. Adequate organ function, defined as:\n\n    1. Creatinine clearance ≥ 30 mL\u002Fmin, based on the CKD-EPI Creatinine Equation (2021).\n    2. AST\u002FALT ≤ 5x upper limit of the normal range, unless considered to be due to leukemic involvement.\n    3. Bilirubin ≤ 3x upper limit of the normal range, unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement.\n    4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air, unless considered to be due to leukemic involvement.\n    5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO\u002FMUGA.\n11. ECOG performance status 0, 1, or 2.\n12. Signed informed consent form.\n13. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in the protocol main text.\n14. Willing to participate in the long-term follow-up protocol that is required if CAR T cell therapy is administered.\n\nExclusion Criteria:\n\n1. Subjects with Acute Promyelocytic Leukemia (APL) with t(15;17)\n2. Receipt of previous chemotherapy for AML, as follows:\n\n   a. Prior to apheresis, the following washout periods apply: i. Hydroxyurea: 1 day ii. Hypomethylating agent and\u002For venetoclax: 7 days iii. Small molecule targeted therapy (including tyrosine kinase inhibitors): 3 half-lives or 7 days, whichever is shorter.\n\n   iv. Immune checkpoint inhibitors or other immunological agents: 5 half-lives or 28 days, whichever is shorter.\n\n   v. Investigational products: 5 half-lives or 28 days, whichever is shorter. vi. Any other systemic chemotherapy: 14 days vii. Allogeneic stem cell transplantation: 180 days viii. Donor lymphocyte infusion (DLI): 60 days ix. Craniospinal or total body radiation: 42 days b. After apheresis and prior to lymphodepletion, no treatment for AML is permitted, with the exception of bridging hydroxyurea with a washout period of 1 day prior to the start of the lymphodepletion regimen.\n3. Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.\n4. Previous treatment with investigational gene or cell therapy (including CAR therapy).\n5. Signs or symptoms indicative of CNS leukemia involvement. A CNS evaluation should be performed if CNS involvement is suspected to rule out CNS leukemia involvement.\n6. Pregnant or lactating (nursing) women.\n7. Known HIV infection or active Hepatitis B or Hepatitis C infection.\n8. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).\n9. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n10. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.\n11. Subjects with cardiac arrhythmia, or arrhythmias that are not stable with medical management, within 2 weeks of the Screening\u002FEnrollment visit.\n12. Any uncontrolled active medical disorder that would preclude participation as outlined.\n13. Evidence of another uncontrolled malignancy.\n\nApheresis Eligibility To proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21 days prior to apheresis, unless otherwise specified.\n\nNote: Disease evaluation (bone marrow aspirate and biopsy) to meet inclusion criteria must be completed within 30 days prior to enrollment.\n\nLymphodepleting Chemotherapy Eligibility To proceed with lymphodepleting chemotherapy, enrolled participants must have specific assessments completed and continue to meet all inclusion criteria within 72 hours of initiation of lymphodepletion\n\nCD64 CAR T Infusion Eligibility\n\nParticipants must meet the following criteria in order for cells to be infused (based on labs obtained within 24 hours of cell infusion):\n\n* CD64 CAR T must have met manufacturing criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA)\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* Performance status determination (ECOG must be 0, 1 or 2).\n* Participant remains clinically stable without evidence of vital sign instability including the lack of supportive vasoactive drugs or intensive care support.\n* Must not have ALT\u002FSGPT and AST\u002FSGOT \\> 10x the ULN or total bilirubin \\> 3x the ULN, (unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement)\n* Adequate renal function, as defined in the Inclusion Criteria.\n* No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator.",{"count":163,"type":21},23,[24],"This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ\u002F4-1BB) costimulatory domains in subjects with refractory or relapsed (R\u002FR) acute myeloid leukemia (AML). This CAR T cell product will be referred to as \"CD64 CAR T\" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R\u002FR AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.",[167,168,30,169],"Refractory Acute Myeloid Leukemia (AML)","Relapsed Acute Myeloid Leukemia (AML)","AML (Acute Myeloid Leukemia)",[171,172,173,174],"AML","CD64","CAR T","CAR T cell","2026-06-25",{"date":147,"type":46},{"date":178,"type":21},"2026-06",{"date":180,"type":21},"2032-06",{"name":182,"class":53},"University of Colorado, Denver",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":54},"100578723","phase-2-vedolizumab-plus-post-transplant-cyclophosphamide-and-short-course-tacrolimus-for-the-prevention-of-graft-versus-host-disease-in-patients-undergoing-allogeneic-hematopoietic-cell-transplantation-after-reduced-intensity-conditioning-100578723","NCT06815003","Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning","Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 and ≤ 80 years old\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8\u002F8 match related\u002Funrelated donor (A, B, C, DR by high resolution typing)\n\n  * Acute Leukemias (acute myeloid leukemia \\[AML\\] or acute lymphoblastic leukemia \\[ALL\\]) in complete remission with bone marrow (BM) blast of \\\u003C 5%\n  * Myelodysplastic syndrome (blast \\\u003C 10%)\n  * Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT\n  * Chronic myelomonocytic leukemia (CMML)\n* Hemoglobin ≥ 9g\u002FdL (within 30 days prior to day 1 of protocol therapy)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 2.0 mg\u002FdL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \\\u003C 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≤ 1.5 mg\u002FdL or ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Tuberculosis test (within 30 days prior to day 1 of protocol therapy)\n\n  * Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy\n\n  * Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded\n* Other investigational drugs for GVHD prophylaxis\n* Herbal medications\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","80 Years",{"count":192,"type":21},35,[66],"This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.",[117,28,196,146,30,124],"Chronic Myelomonocytic Leukemia",{"date":147,"type":46},{"date":199,"type":46},"2025-04-18",{"date":201,"type":21},"2028-10-15",{"name":132,"class":53},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":54},"100553947","phase-1-dr-18-to-prevent-or-treat-acute-myeloid-leukemia-or-myelodysplastic-syndrome-relapse-after-hematopoietic-cell-transplantation-the-dr-dream-trial-100553947","NCT06492707","DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hematopoietic Cell Transplantation, the DR. DREAM Trial","Decoy-Resistant Interleukin-18 (DR-18) for Relapse, Pre-emptive Treatment or Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (DR. DREAM)","Inclusion Criteria:\n\n* ≥ 18 years of age (no upper age limit)\n* The most recent HCT was from a 10\u002F10 human leukocyte antigen (HLA)-matched related or unrelated donor (assessed at HLA-A, B, C, DR, DQ)\n* Evidence of blood count recovery at any time post-HCT defined as absolute neutrophil count (ANC) ≥ 0.5 x 10\\^9\u002FL for ≥ 3 consecutive days and platelets ≥ 30 x 10\\^9\u002FL (independent of granulocyte colony-stimulating factor \\[G-CSF\\] or platelet transfusions for 5 days). (Blood count recovery may not be sustained.)\n* Absent, stable or reducing immune suppression in the preceding 4 weeks without GvHD flares\n* Karnofsky performance status (KPS) ≥ 80%\n* Agrees to use a suitable method of contraception during study treatment and for 4 months after the last dose of DR-18\n* Capable of providing informed consent\n* GROUP 1: Documented persistent or recurrent measurable residual AML or MDS after HCT, defined as bone marrow blasts \\\u003C 5% by morphology (unless suspected to be regenerative) and malignant bone marrow blasts \\\u003C 5% by flow cytometry.\n\n  * Note: MRD (\\\u003C 5% malignant blasts) must be detected with flow cytometry testing at University of Washington Medical Center (UWMC)\u002FFred Hutchinson Cancer Center (Fred Hutch) clinical laboratory\n* GROUP 1: Absence of circulating malignant blasts detected by the complete blood count (CBC)\n* GROUP 1: Absence of extramedullary disease\n* GROUP 1: Post-HCT restaging never detected overt relapse or disease persistence, defined as ≥ 5% (non-regenerative) blasts by morphology or flow cytometry, or circulating malignant blasts on CBC, or extramedullary disease\n* GROUP 1: At least 60 days have elapsed since the HCT donor cell infusion (HCT day 0). (There is no upper limit to the time elapsed since HCT.)\n* GROUP 1: No Food and Drug Administration (FDA)-approved targeted therapy for the participant's AML or MDS is available, or if such therapy is available, that class of drugs previously failed for the participant or the participant was intolerant of the therapy\n* GROUP 2: HCT is with post-transplant cyclophosphamide or other form of in vivo or ex-vivo T cell depletion\n* GROUP 2: Informed consent was signed pre-HCT or latest day 28 post-HCT. (Treatment may start as early as 30 days post-HCT.)\n* GROUP 2-ONLY IF AML BY WORLD HEALTH ORGANIZATION (WHO) OR INTERNATIONAL CONSENSUS CLASSIFICATION (ICC) 2022 CRITERIA: Pre-HCT bone marrow shows residual leukemia by flow cytometry (MRD or overt disease with ≥ 5% blasts)\n* GROUP 2-ONLY IF AML BY WHO OR ICC 2022 CRITERIA: The participant had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy prior to HCT\n* GROUP 2-ONLY IF MDS BY WHO OR ICC 2022 CRITERIA: Any one of the following high-risk features was detected in the pre-HCT disease course:\n\n  * International Prognostic Scoring System-MDS (IPSS-M) score \"very high\" risk\n  * TP53 pathogenic or likely pathogenic mutation with variant allele frequency (VAF) ≥ 50%\n  * TP53 pathogenic or likely pathogenic mutation with VAF \\\u003C 50% and complex cytogenetics or 5q or 7q cytogenetic abnormalities\n  * Biallelic TP53 mutations\n  * The patient had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy and the pre-HCT bone marrow evaluation still shows \\> 5% malignant blasts by flow cytometry\n\nExclusion Criteria:\n\n* Cellular immunotherapy or new targeted therapy in the 4 weeks prior to the first DR-18 injection\n* History of grade 3 or 4 acute GvHD after the most recent HCT\n* History of moderate or severe chronic GvHD after the most recent HCT\n* Active acute or chronic GvHD or other immunologic phenomenon (e.g., immune cytopenias, cryptogenic immunologic pneumonia) in last month requiring systemic therapy (Hydrocortisone or prednisone for adrenal insufficiency at ≤ 10 mg\u002Fday prednisone-equivalent is permitted.)\n* Active moderate-severe thrombotic microangiopathy (TMA) as evidenced by any of the following: \\> 10 schistocytes per high-power field, or required anti-C5 or other anti-complement therapy for TMA in the prior 4 weeks, any of the following manifestations if attributed to TMA in the prior 4 weeks: hypertension, worsening or new renal insufficiency, ≥ 2+ proteinuria, hematochezia, seizure, transient or ongoing neurologic deficits\n* Renal insufficiency: Estimated glomerular filtration rate (eGFR) (calculated per the performing laboratory's standard formula) or measured 24 hour (hr.) creatinine clearance \\\u003C 30 mL\u002Fmin\n* Hemodialysis in the prior 4 weeks\n* Major cardiac event requiring evaluation in the emergency room (ER) or hospitalization in the past 4 weeks\n* New York Heart Association (NYHA) class II or higher congestive heart failure (CHF) in the past 4 weeks\n* Uncontrolled cardiac arrhythmias, including atrial fibrillation\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%\n* Liver dysfunction: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 x upper limit of normal (ULN) or bilirubin \\> 3 x ULN\n* Active uncontrolled infection. Note: Examples of controlled infections:\n\n  * Bacterial infection may be still requiring antibiotics at the time of enrollment, but clinical signs and symptoms of the infection should be improving. If the participant had bloodstream infection, negative blood cultures off antibiotics must be documented prior to initiating DR-18 treatment. For urinary tract infection, a repeat urine culture must be sterile prior to initiating DR-18. Radiographic improvement of bacterial pneumonia may lag behind clinical improvement so is not mandatory prior to DR-18 initiation\n  * Fungal infection may be still requiring antifungal medication at the time of enrollment, but evidence of clinical response to antifungal medication (such as regression of lesions on chest CT) must be available at the time of enrollment\n  * Asymptomatic shedding of respiratory viruses after cessation of antiviral therapy, or if not specifically treated with antiviral therapy, is permitted\n  * Cytomegalovirus (CMV) viremia or organ infection meeting institutional criteria for CMV treatment with antiviral therapy such as ganciclovir, valganciclovir or foscarnet must be on maintenance phase of treatment or must have completed treatment and must not be in the induction treatment phase at the time of enrollment. Low-level CMV viremia not meeting institutional criteria for antiviral therapy is permitted, including low-level viremia in patients receiving CMV prophylaxis with letermovir\n* Any of the following: Pulmonary dysfunction requiring supplemental oxygen, even intermittently, in the past 2 weeks; corrected diffusion capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) \\\u003C 60% predicted; bronchiolitis obliterans syndrome; prior diagnosis of idiopathic pulmonary fibrosis; prior diagnosis of drug-induced pneumonitis; cryptogenic organizing pneumonia under active treatment\n* Seizure in the past 4 weeks or significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, such as Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, epilepsy, prior symptomatic ischemic or hemorrhagic stroke, or transient ischemic attack, unless approved by principal investigator (PI). Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments\n* Concurrent use of other investigational anti-cancer agents\n* Peripheral blood T cell chimerism \\\u003C 40%\n* Pregnant or breastfeeding",{"count":211,"type":21},40,[24],"This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and\u002For effective in treating patient with relapsed or persistent AML or MDS after HCT.",[28,30,215,216],"Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","2026-06-24",{"date":219,"type":46},"2026-06-26",{"date":221,"type":46},"2024-09-23",{"date":223,"type":21},"2028-10-01",{"name":225,"class":53},"Fred Hutchinson Cancer Center",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":54},"100612122","study-of-nk-cells-in-the-monitoring-of-patients-with-acute-leukemia-or-myelodysplasia-100612122","NCT07249476","Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia","ENKLA-M : Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia","ENKLA-M","INCLUSION CRITERIA\n\n* Adult patients diagnosed with acute myeloid leukaemia (LAM), acute lymphoblastic leukaemia (LAL) or myelodysplastic syndrome (SMD).\n* Adult patients receiving a HSC transplant.\n* Adult patients receiving or not AZA treatment after transplantation.\n* Patients who have signed a consent form.\n* Patients affiliated with a social security system. EXCLUSION CRITERIA\n* Minors,\n* Pregnant and\u002For breastfeeding women\n* Adult patients under guardianship,\n* Protected persons.",{"count":235,"type":21},55,"OBSERVATIONAL","The aim of the ENKLA-M study is to collect samples from patients with acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), and myelodysplastic syndrome (MDS) to study the evolution of blast phenotype (NK receptor ligands and adhesion molecules) and the biology of patients' NK cells). To do this, blood and bone marrow samples will be collected from patients at diagnosis in order to characterize: (I) the phenotype of ALL and AML blasts with respect to NK receptor ligands and adhesion molecules; (II) the phenotypic profile of NK cells, (III) to further characterize the NK cell repertoire dynamics over time (day 30, day 60, day 90, 6 months, and 1 year), focusing on NK cell populations identified in healthy individuals as particularly effective against leukemia, by defining their phenotypic and transcriptomic profiles; and (IV) the impact of azacitidine (AZA) and donor lymphocyte infusions (DLI) on the biology of NK cells in transplanted patients. Clinical data and KIR\u002FHLA genetic profiles will be used to analyze all NK phenotypic and functional data, with the aim of better defining: (i) the key molecular interactions between NK cells and leukemic cells; (ii) markers of NK cell anti-leukemic efficacy during hematopoietic reconstitution; and (iii) whether AZA\u002FDLI treatment enhances the functional potential of NK cells via KIR-HLA interaction, thereby improving their effectiveness against residual disease.",[239,240,30],"Leukaemia (Acute Myeloid)","Leukaemia (Acute Lymphoblastic)",[242,243,244,245,246],"VIDAZA","CSH graft","haematopoietic stem cell","natural killer cells","NK Cells","2026-06-23",{"date":217,"type":46},{"date":250,"type":21},"2026-06-01",{"date":50,"type":21},{"name":253,"class":53},"Nantes University Hospital",{"id":255,"slug":4,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":67,"conditions":258,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":262,"locationsCount":263},"100482619",{"count":64,"type":21},[66],[28,69,70,71,30],{"date":217,"type":46},{"date":75,"type":46},{"date":77,"type":21},{"name":79,"class":80},347,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100560461","phase-2-testing-the-addition-of-an-idh2-inhibitor-enasidenib-to-usual-treatment-cedazuridine-decitabine-for-higher-risk-myelodysplastic-syndrome-mds-with-idh2-mutation-a-myelomatch-treatment-trial-100560461","NCT06577441","Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)","A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study","Inclusion Criteria:\n\n* GENERAL MYLEOMATCH REGISTRATION CRITERIA:\n\n  * Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team.\n  * Participants must not have received prior anti-cancer therapy for AML or MDS.\n\n    * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.\n    * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility.\n  * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g\u002Fm\\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine).\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \\[g-CSF\\], thrombopoietin \\[TPO\\] agonist), lenalidomide or luspatercept is allowed with a maximum limit of 1 month of exposure.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x upper limit of normal (ULN).\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL\u002Fmin\n\n  * To be calculated using Cockroft Gault formula.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN).\n\n  * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)\u002FALT (SGPT) ≤ 3.0 x upper limit of normal (ULN)\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL\u002Fmin\n\n  * To be calculated using Cockroft Gault formula.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.",{"count":272,"type":21},54,[66],"This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.",[30],"2026-06-18",{"date":278,"type":46},"2026-06-22",{"date":280,"type":46},"2025-06-12",{"date":282,"type":21},"2027-03-01",{"name":79,"class":80},140,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":54},"100180554","phase-2-methylprednisolone-horse-anti-thymocyte-globulin-cyclosporine-filgrastim-andor-pegfilgrastim-or-pegfilgrastim-biosimilar-in-treating-patients-with-aplastic-anemia-or-low-or-intermediate-risk-myelodysplastic-syndrome-100180554","NCT01624805","Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and\u002For Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome","Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low\u002FInt-1 Risk Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n1. Patients with the diagnosis of MDS (Low, Int-1 by IPSS, or hypocellular) who are either previously treated or untreated are eligible for this trial.\n2. Patients with the diagnosis of aplastic anemia who are either previously treated or untreated are eligible if they are not currently candidates for an allogeneic stem cell transplant.\n3. Patients ages 18 years and older are eligible\n4. Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy for at least 2 weeks prior to entering this study, and have recovered from the toxic effects of that therapy to grade 1 or less.\n5. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST \\\u003C3 x ULN)\n   * kidney function (creatinine \\\u003C 2.5 x ULN ).\n6. ECOG performance status of ≤ 2.\n7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n8. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n9. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n10. Patients should have an indication for therapy for their disease such as transfusion dependence or morbidity associated with their cytopenia(s) such as bleeding, severe fatigue, or frequent\u002Fmultiple infections (eg. neutropenia).\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated on this study.\n2. Known HIV infection.\n3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Patient with documented hypersensitivity to any of the component medications.",{"count":284,"type":21},[66],"This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and\u002For pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and\u002For pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.",[296,297,30,298],"Aplastic Anemia","de Novo Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome",{"date":278,"type":46},{"date":301,"type":46},"2012-06-25",{"date":303,"type":21},"2029-06-30",{"name":305,"class":53},"M.D. Anderson Cancer Center",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100418248","phase-1-the-pediatric-acute-leukemia-pedal-screening-trial---a-study-to-test-bone-marrow-and-blood-in-children-with-leukemia-that-has-come-back-after-treatment-or-is-difficult-to-treat---a-leukemia--lymphoma-society-and-childrens-oncology-group-study-100418248","NCT04726241","The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study","Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias","Inclusion Criteria:\n\n* Patients must be less than 22 years of age at the time of study enrollment\n* Patient must have one of the following at the time of study enrollment:\n\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) AML as defined in protocol\n\n    * This includes isolated myeloid sarcoma\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)\n  * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:\n\n    * Second or greater B-ALL medullary relapse, excluding KMT2Ar\n    * Any first or greater B-ALL medullary relapse involving KMT2Ar\n    * Any first or greater T-ALL medullary relapse with or without KMT2Ar\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) treatment-related AML (t-AML)\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","22 Years",{"count":315,"type":21},960,[24,66],"This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.",[117,28,70,319,320,30,321,322],"Juvenile Myelomonocytic Leukemia","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome Post Cytotoxic Therapy","Myeloid Leukemia Associated With Down Syndrome","2026-06-16",{"date":276,"type":46},{"date":326,"type":46},"2022-04-18",{"date":328,"type":21},"2030-12-31",{"name":330,"class":53},"PedAL BCU, LLC",183,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":133},"100294495","phase-1-sl-401-in-combination-with-azacitidine-or-azacitidinevenetoclax-in-acute-myeloid-leukemia-aml-high-risk-myelodysplastic-syndrome-mds-or-blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-100294495","NCT03113643","SL-401 in Combination With Azacitidine or Azacitidine\u002FVenetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\nHistologically confirmed diagnosis of acute myeloid leukemia (AML) \\[Cohort B\\] or myelodysplastic syndrome (MDS) \\[Cohort A\\] or BPDCN \\[Cohort C\\] per 2016 WHO criteria\n\nCD123 \u002F IL3RA expression on the subject's AML or MDS blasts or BPDCN cells determined locally within 3 months of first protocol treatment\n\nAge \\>= 18 years with relapsed or refractory AML (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with treatment-naïve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factors (see APPENDIX A for unfitness definitions) (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with MDS and \\> 10% myeloblasts in the bone marrow \\[Cohort A\\]\n\nOR\n\nAge \\>= 18 years with relapsed or refractory BPDCN (hydroxyurea is not considered a prior treatment regimen) \\[Cohort C\\]\n\nAdequate organ function as defined by:\n\nAlbumin \\> 3.2 g\u002FdL (in the absence of receipt of intravenous albumin in the previous 72 hours) Serum creatinine \\\u003C 1.5x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5x ULN Total bilirubin \\\u003C 1.5x ULN (if thought to be \\> 1.5x ULN due to Gilbert's disease or the patient's AML, must discuss with the PI) Creatine phosphokinase (CPK) \\\u003C 2.5x ULN Left ventricular ejection fraction \\> institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment\n\n\\[Cohorts B and C\\] WBC \\\u003C 20,000 \u002F uL on day of first therapy, cytoreduction may be achieved using hydroxyurea\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nAble to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment\n\nWomen of child-bearing potential must agree to use adequate contraception for the duration of study participation and for 2 months after completion of protocol treatment.\n\nMen treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 2 months after completion of protocol treatment.\n\nExclusion Criteria:\n\nPrior treatment with venetoclax \\[Cohorts B or C\\], unless it was last taken \\>2 months before protocol therapy\n\nDiagnosis of acute promyelocytic leukemia\n\nReceived treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment, except for intrathecal chemotherapy. Prior and concurrent hydroxyurea is permitted.\n\nHematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease\n\nActive CNS involvement by AML or BPDCN. Screening lumbar puncture (LP) required for patients with BPDCN. If history of treated CNS involvement, must have had two consecutive negative LPs since last CNS involvement, which may include the screening LP\n\nKnown positive status for HIV infection; known active hepatitis B or hepatitis C infection\n\nClinically significant cardiopulmonary disease including uncontrolled or NYHA class 3 or 4 congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within 6 months of first protocol treatment, or QTc \\> 480 ms\n\nPatients with known active advanced malignant solid tumors are excluded (except for basal or squamous skin cancers, or carcinomas in situ). Patients with additional hematologic malignancies that require treatment are excluded.\n\nPregnant women are excluded from this study because there is an unknown but potential risk for adverse events in the developing fetus with SL-401, azacitidine, and venetoclax (negative urine or serum pregnancy test required within 14 days of Cycle 1, Day 1). Because nursing infants have unknown potential for adverse events secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with SL-401, azacitidine, and venetoclax.\n\nPatients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. Patients with active infection are permitted to enroll provided that the infection is controlled\n\n\\[Cohorts B and C\\] Patients with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)\n\n\\[Cohorts B and C\\] Patients on strong CYP3A inducers within 7 days of first dose of study treatment.",{"count":340,"type":21},72,[24],"This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS.\n\nThe interventions involved in this study are:\n\n* SL-401\n* Azacitidine\n* Venetoclax",[28,30,344],"Blastic Plasmacytoid Dendritic Cell Neoplasm",[28,30,344,346],"BPDCN","2026-06-15",{"date":349,"type":46},"2026-06-17",{"date":351,"type":46},"2017-06-26",{"date":353,"type":21},"2027-05-31",{"name":355,"class":53},"Dana-Farber Cancer Institute",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":4},"100604744","phase-2-testing-the-use-of-an-idh1-inhibitor-olutasidenib-in-acute-myeloid-leukemia-added-to-astx727-and-venetoclax-in-high-risk-mds-added-to-astx727-and-alone-in-low-risk-mds-a-myelomatch-treatment-substudy-100604744","NCT07153497","Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy)","A Randomized Phase 2 Trial of Olutasidenib-Based Therapies in Patients With Newly Diagnosed IDH1-Mutant Myeloid Malignancies: A MyeloMATCH Substudy","Inclusion Criteria:\n\n* Patient must be enrolled on the MYELOMATCH Master Screening and Reassessment Protocol (MSRP), determined to have an IDH1-R132 mutation and assigned to this trial via MATCHBox\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1):\n* Documentation of IDH1 mutated MDS or AML\n* COHORT A: Age ≥ 60 years or adults ˂ 60 and ≥ 18 who in the opinion of the treating physician are not candidates for intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology with a morphologically confirmed diagnosis of AML with ≥ 20% myeloblasts in the bone marrow or peripheral blood\n* COHORT B: Age ≥ 18 years with treatment-naïve HR-MDS with an IPSS-R score ≥ 4.0 at time of enrollment\n* COHORT C: Age ≥ 18 years with LR-MDS with an IPSS-R score ≤ 3.5 at time of enrollment and either:\n\n  * RBC-TD anemia (≥ 2 units\u002F8 weeks in the 16 weeks prior to registration) who have failed or are ineligible to erythropoiesis-stimulating agents (ESA) therapy\n  * Presence of either neutropenia (\\\u003C 1 x 10\\^9\u002FL) or thrombocytopenia (\\\u003C 100 x 10\\^9\u002FL) for use as frontline therapy or after failure of prior therapies, including growth factors. Patient must be hypomethylating agent (HMA)-naïve\n* No prior therapy excluding:\n\n  * Cohort A: hydroxyurea and all-trans retinoic acid (ATRA) for AML\n  * Cohort B: ESAs (erythropoiesis-stimulating agents) and\u002For TGF-β inhibitors for HR-MDS\n  * Cohort C: ESAs (erythropoiesis-stimulating agents, TGF-β inhibitors, telomerase inhibitors, and\u002For G-CSF for LR-MDS)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3\n* Creatinine clearance ≥ 30 mL\u002Fmin (using the Cockcroft-Gault equation)\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n\n  * Unless the increase is due to Gilbert's disease as determined per physician discretion\u002Finstitutional practice\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x upper limit of normal (ULN)\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test must be done ≤ 7 days prior to registration. (Cohorts B and C only)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. A corrected QT interval \\\u003C 480 msec (calculated using the Fridericia's formula \\[QTcF\\]) excluding patients with a right bundle branch block (RBBB) after approval of the principal investigator (PI)\n* No known medical condition causing an inability to swallow, tolerate oral medications and must have no known malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or small bowel resection) that may significantly alter the absorption of the study drugs\n* RE-REGISTRATION ELIGIBILITY CRITERIA FOR COHORT B, ARM 3 (STEP 2): Patients on the ASTX727 monotherapy arm (Cohort B-Arm 3) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment\n* RE-REGISTRATION ELIGIBILITY CRITERIA FOR COHORT B, ARM 3 (STEP 2): ECOG Performance Status ≤ 3\n* RE-REGISTRATION ELIGIBILITY CRITERIA FOR COHORT B, ARM 3 (STEP 2): Creatinine clearance ≥ 30 mL\u002Fmin (using the Cockcroft-Gault equation)\n* RE-REGISTRATION ELIGIBILITY CRITERIA FOR COHORT B, ARM 3 (STEP 2): Total bilirubin ≤ 3 x upper limit of normal (ULN)\n\n  * Unless the increase is due to Gilbert's disease as determined per physician discretion\u002Finstitutional practice\n* RE-REGISTRATION ELIGIBILITY CRITERIA FOR COHORT B, ARM 3 (STEP 2): AST (SGOT)\u002FALT (SGPT) ≤ 3 x upper limit of normal (ULN)",{"count":364,"type":21},132,[66],"This phase II MyeloMATCH treatment substudy tests the addition of olutasidenib to usual treatment in patients with higher-risk myelodysplastic syndrome (MDS) or patients with acute myeloid leukemia (AML) with a mutation in the IDH1 gene. Olutasidenib blocks the protein made by the mutated IDH1 gene. Blocking this protein may help keep cancer cells from growing. For patients with MDS, olutasidenib will be added to decitabine-cedazuridine (also called ASTX727). Decitabine is in a class of medications called hypomethylating agents and is the standard treatment for MDS. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The cedazuridine makes it possible to take the decitabine by mouth. Adding olutasidenib to the usual treatment for MDS (ASTX727) may increase the likelihood of going into remission. For patients with AML, olutasidenib and ASTX727 will be combined with venetoclax, a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Adding olutasidenib to the usual treatment for AML (ASTX727 and venetoclax) may increase the likelihood of going into remission. For low risk MDS, the substudy tests whether giving olutasidenib alone helps improve blood counts.",[28,30],"2026-06-13",{"date":323,"type":46},{"date":371,"type":21},"2026-05-27",{"date":373,"type":21},"2030-04-26",{"name":79,"class":80},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":401},"100625426","phase-3-a-study-to-compare-elritercept-with-epoetin-alfa-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100625426","NCT07422480","A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions","ELRiSE MDS","Inclusion Criteria\n\n1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.\n3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\\>) 14 days after red blood cell (RBC) transfusion or greater than (\\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.\n4. Bone marrow less than (\\\u003C) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.\n5. Endogenous serum erythropoietin s (EPO) level of \\\u003C500 U\u002FL. Should be results from blood samples collected \\>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.\n6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units\u002F8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.\n\n   • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g\u002FdL) (5.6 millimoles per liter (mmol\u002FL)) with symptoms of anemia (or ≤7 g\u002FdL \\[4.3 mmol\u002FL\\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.\n\n   • RBC transfusions administered when hemoglobin (Hgb) levels were \\>9.0 g\u002FdL (or \\>7 g\u002FdL in the absence of symptoms) and\u002For RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.\n7. Hgb \\\u003C11.0 g\u002FdL (6.8 mmol\u002FL) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.\n8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria\n\n\u003C!-- -->\n\n1. Prior therapy with any of the following:\n\n   1. Epoetin alfa\n\n      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.\n   2. Darbepoetin\n   3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.\n   4. Immunomodulatory drug (IMiDs) including lenalidomide\n\n      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.\n   5. Hypomethylating agent\n\n      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.\n   6. Luspatercept, sotatercept, imetelstat, or elritercept\n   7. Immunosuppressive therapy\n   8. Hematopoeitic cell transplant\n   9. Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n   10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed\n   11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.\n   12. Investigational agent or any other agent intended for treatment MDS treatment\n2. Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.\n3. Known history of diagnosis of acute myeloid leukemia (AML).\n4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.\n5. Clinically significant cardiovascular disease defined as:\n\n   1. New York Heart Association heart disease class III or IV\n   2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during screening\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening\n6. Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.\n7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n   1. Basal or squamous cell carcinoma of the skin;\n   2. Carcinoma in situ of the cervix;\n   3. Carcinoma in situ of the breast;\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n10. History of solid organ or bone marrow transplantation.\n11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.\n12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n13. Body mass index ≥ 40 kilograms per square meter (kg\u002Fm\\^2).\n14. Major surgery within 28 days before randomization.\n15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.\n16. History of allergy\u002Fanaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.\n17. History of pure red cell aplasia and\u002For antibody against erythropoietin (EPO).\n18. Any of the following laboratory abnormalities:\n\n    1. ANC \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002FL).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or ≥450,000\u002FμL (450×109\u002FL).\n    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).\n    4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \\\u003C3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    5. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.\n    6. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    7. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    8. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n19. Ongoing participation in another interventional clinical trial.\n20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.\n21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.\n22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":384,"type":21},300,[386],"PHASE3","The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.",[30,389],"Anemia",[391,392],"TAK-226","Drug therapy",{"date":347,"type":46},{"date":395,"type":46},"2026-05-21",{"date":397,"type":21},"2033-10-01",{"name":399,"class":400},"Takeda","INDUSTRY",154,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},"100553282","phase-1-testing-the-anti-cancer-drug-cirtuvivint-and-its-combination-with-astx727-to-improve-outcomes-in-patients-with-acute-myeloid-leukemia-and-myelodysplastic-syndromes-100553282","NCT06484062","Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes","A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* In Cohorts I and II, patients must have R\u002FR AML or MDS (venetoclax naïve or venetoclax exposed)\n\n  * Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission (CR), CR with partial hematologic recovery (CRh), or CR with incomplete hematologic recovery (CRi). Patients with a mutation in FLT3, IDH1 or IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3, IDH1 or IDH2 inhibitor before enrolling on study. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g., 7+3, mitoxantrone, etoposide, cytarabine \\[MEC\\], high-dose cytarabine \\[HIDAC\\], reinduction chemotherapy such as 5 + 2, etc.) or, (ii) ≥ 2 cycles of hypomethylating agent (HMA)\u002Fvenetoclax or low-dose cytarabine (LDAC)\u002Fglasdegib or, (iii) ≥ 4 cycles of HMA monotherapy. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Patients with MDS\u002FAML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS\u002FAML, and not as newly-diagnosed AML (i.e. the patients' treatment history for eligibility purposes does not reset)\n  * Relapsed MDS is defined as: (i) Intermediate, high, or very high-risk disease by International Prognostic Scoring System-Revised (IPSS-R) and, (ii) Any relapse after achieving any 2023 IWG MDS defined response\n  * Refractory MDS is defined as: (i) Intermediate, high, or very high-risk disease by IPSS-R and \\> 5% blasts in the bone marrow or peripheral blood, (ii) Failure to achieve a response (as per IWG 2006 criteria) after ≥ 4 cycles of HMA monotherapy, or (iii) ≥ 2 cycles of HMA + venetoclax\n* In Cohort III, patients must have prior untreated high-risk MDS\n\n  * MDS with \\> 5% blasts in the bone marrow or peripheral blood AND\n  * IPSS-R high or very high-risk disease OR\n  * Molecular International Prognostic Scoring System (IPSS-M) high or very high-risk disease\n  * No more than one single prior cycle of DNMTi therapy\n  * Prior use of erythropoiesis stimulating agents (ESA), thrombopoietin agonists, lenalidomide, and luspatercept are allowed\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of SM08502 (cirtuvivint) in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* If female, patient must be either:\n\n  * Postmenopausal (surgically sterile or age \\> 55 years with no menses for 12 or more months without an alternative medical cause or age equal to 55 or less with no menses for 12 or more months without an alternative medical cause and a follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL); or\n  * Of children bearing potential. These patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Patient must agree to have a negative urine or serum beta-human chorionic gonadotropin (HCG) test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible\n* The effects of SM08502 (cirtuvivint) and ASTX727 on the developing human fetus are unknown. For this reason, and because these agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and during the treatment therapy. Women of childbearing age should agree to use adequate contraception for 7 months after completion of SM08502 (cirtuvivint) administration. For ASTX727, adequate contraception must continue for at least 6 months after last dose of ASTX727. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study and at least 4 months after the last dose of SM08502 (cirtuvivint) and 3 months after last dose of ASTX727. Women who are lactating must refrain from breastfeed during the study and at least for two weeks after last dose of ASTX727\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia or abnormal blood counts\n* Patients who are receiving any other investigational agents\n* Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease. Patients are not allowed to receive concurrent therapy such as cytotoxic chemotherapy or radiation therapy for another cancer. Patients on hormonal adjuvant therapy for non-metastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study principal investigator (PI)\n* Patient is receiving known inhibitors or activators of flavin-containing monooxygenases (FMO1 or FMO3), and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start. Known inhibitors of FOMO are chlorpromazine and imipramine\n* Patient is receiving strong inhibitors or strong inducers of CYP3A4\u002F5 and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start\n\n  * Strong inhibitors include grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits (e.g., Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n  * Strong inducers include phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, and St. John's Wort. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance.\n  * While moderate inhibitors or moderate inducers of CYP3A4\u002F5 are not an exclusion criteria for the trial, it is preferred that moderate inhibitors or moderate inducers of CYP3A4\u002F5 be replaced prior to the first dose of SM08502 (cirtuvivint) and during study conduct where this is possible.\n\n    * Moderate inhibitors include erythromycin, ciprofloxacin, verapamil, diltiazem, atazanavir, fluconazole, darunavir, delavirdine, amprenavir, fosamprenavir, aprepitant, imatinib, tofisopam, and cimetidine. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n    * Moderate inducers include bosentan, efavirenz, etravirine, modafinil, and nafcillin. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SM08502 (cirtuvivint) or ASTX727\n* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: patients with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients who had prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis, are allowed to participate. If there is no known history of HBV infection no HBV studies need to be obtained. If there is no known history of HCV infection, no HCV studies need to be obtained\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study because SM08502 (cirtuvivint) is a small molecule inhibitor of CLK DYRK with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SM08502 (cirtuvivint), breastfeeding should be discontinued if the mother is treated with SM08502 (cirtuvivint). These potential risks may also apply to other agents used in this study\n* Patients with acute promyelocytic leukemia\n* Subject has symptomatic central nervous system (CNS) involvement with AML\n* Patient has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding and\u002For uncontrolled infection\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including uncontrolled New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Patient needs to be able to swallow pills\n* Patient has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Subject has prolonged corrected QC (QTc) interval (Fridericia's correction \\[QTcF\\]) ≥ 480 ms or known family history of long QT interval syndrome at screening",{"count":272,"type":21},[24],"This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and\u002For effective in treating patients with AML and MDS.",[28,30,413,215,216,414,415,416,417],"Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Refractory Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-10",{"date":420,"type":46},"2026-06-11",{"date":422,"type":46},"2025-08-15",{"date":424,"type":21},"2028-06-01",{"name":79,"class":80},22,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":444,"locationsCount":54},"100400356","phase-2-cpx-351-and-ivosidenib-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100400356","NCT04493164","CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)\n* Treatment naive or relapsed\u002Frefractory AML who are eligible for intensive chemotherapy. Patients with high-risk MDS or MPN (defined as International Prognostic Scoring System Revised \\[IPSS-R\\] score ≥ 4 or dynamic \\[D\\]-IPSS ≥ 3) may also be eligible after discussion with the PI\n* Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 x ULN unless deemed to be related to underlying leukemia\n* Adequate renal function including creatinine clearance ≥ 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n* Willing and able to provide informed consent\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Patients who have previously received CPX-351.\n* Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea, and\u002For cytarabine (1 or 2 doses; up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy.\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction \\\u003C 45%.\n* Patients with prior anthracycline exposure of \\> 360 mg\u002Fm2 daunorubicin (or equivalent), or \\> 210 mg\u002Fm2 daunorubicin (or equivalent) in patients with prior mediastinal radiation.\n* QTc interval using Fridericia's formula (QTcF) \\> 470 msec. A prolonged QTc interval in the setting of right bundle branch block is permitted after discussion with the PI.\n* Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).\n* Subjects with a known medical history of progressive multifocal leukoencephalopathy (PML).\n* Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing\n* Patients with a diagnosis of acute promyelocytic leukemia (APL).\n* Unresolved toxicities \\> grade 1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery.",{"count":435,"type":21},30,[66],"This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.",[439,30,124,215,415],"Acute Myeloid Leukemia With Gene Mutations",{"date":151,"type":46},{"date":442,"type":46},"2020-12-30",{"date":424,"type":21},{"name":305,"class":53},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":54},"100440040","phase-1-astx727-venetoclax-and-gilteritinib-for-the-treatment-of-newly-diagnosed-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100440040","NCT05010122","ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults \\>= 18 years with newly diagnosed FLT3-mutated AML. Patients should meet the following criteria:\n\n    * Confirmed newly diagnosed AML with FLT3 mutation\n    * Ineligible for induction therapy defined as\n\n      * Either age \\>= 75\n      * Or 18-74 with at least one comorbidity (congestive heart failure \\[CHF\\] requiring therapy or ejection fraction \\[EF\\] =\\\u003C 50%, diffusion capacity of the lung for carbon monoxide \\[DLCO\\] =\\\u003C 65% or forced expiratory volume in 1 second \\[FEV1\\] =\\\u003C 65%, or Eastern Cooperative Oncology Group \\[ECOG\\] 2 or 3, or other significant co-morbidity precluding use of cytotoxic chemotherapy as approved by the principal investigator (PI)\n  * Phase II cohort B: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or MDS that is intermediate-2 or high-risk by the International Prognostic Scoring System who have received 1 prior therapy\n  * For all cohorts, patients with either FLT3-ITD or FLT3 D835 mutations will be eligible\n* Performance status =\\\u003C 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin =\\\u003C 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n* Hydroxyurea or one dose of cytarabine up to 1000 mg is allowed to reduce the white blood cell (WBC) to less than 25 x 10\\^9\u002FL prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior therapies\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed including prior hypomethylating agent (HMA) therapy for MDS. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: Patients with \\>= 3 prior lines of therapy are not eligible. Stem cell transplantation, treatment given only for cytoreductive purposes (e.g. hydroxyurea), and growth factors do not count as lines of therapy for this purpose. Prior therapy with venetoclax and gilteritinib is allowed\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT (QTc) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association Criteria\n* Active central nervous system leukemia\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of CYP3A or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted. Use of hydroxyurea or one dose cytarabine to reduce WBC below 25 prior to initiation of study treatment is recommended\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to use effective methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib\n* Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study",{"count":453,"type":21},42,[24,66],"This phase I\u002FII trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.",[28,30,215,415],"2026-06-09",{"date":420,"type":46},{"date":460,"type":46},"2021-07-08",{"date":462,"type":21},"2028-01-30",{"name":305,"class":53},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100287143","phase-1-a-vaccine-vsv-hifn-nis-with-or-without-cyclophosphamide-and-combinations-of-ipilimumab-nivolumab-and-cemiplimab-in-treating-relapsed-or-refractory-multiple-myeloma-acute-myeloid-leukemia-or-lymphoma-100287143","NCT03017820","A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory disease as follows:\n\n  * Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent\n  * All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant\n  * Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic\u002Fdendritic cell neoplasms (HCN) at any stage\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n  * Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden\n  * Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL by protein electrophoresis\n  * \\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * Serum immunoglobulin free light chain \\>= 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: No ANC restriction (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: PLT \\>= 10,000\u002FuL (transfusion to get platelets \\>= 10,000 is allowed) (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Hemoglobin \\>= 7.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \\[ISTH\\] criteria)\n* FOR TCL\u002FBCL ONLY: ANC \\>= 1,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: PLT \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* FOR HCN ONLY: ANC \\>= 1,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: PLT \\>= 100,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Hemoglobin \\>= 8.0 g\u002Fdl obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \\>= 1.5 cm or tumor cells in the blood \\>5 x10\\^9\u002FL. NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* AML ONLY: Current disseminated intravascular coagulopathy (DIC)\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Multiple myeloma only: \\> 25% plasma cells or plasmacytoma \\> 5cm in largest diameter\n  * Lymphoma or HCN only: Any mass \\>5cm\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of AITL\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of cutaneous TCL",{"count":472,"type":21},99,[24],"This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.",[476,477,30,298,478,479,480,481,482,483,484,415,485,486,487,488,489,490,491],"B-Cell Non-Hodgkin Lymphoma","Histiocytic and Dendritic Cell Neoplasm","Recurrent Adult Acute Myeloid Leukemia","Recurrent Anaplastic Large Cell Lymphoma","Recurrent Angioimmunoblastic T-Cell Lymphoma","Recurrent Mycosis Fungoides","Recurrent Plasma Cell Myeloma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent T-Cell Non-Hodgkin Lymphoma","Refractory Anaplastic Large Cell Lymphoma","Refractory Angioimmunoblastic T-Cell Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Refractory Plasma Cell Myeloma","Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory T-Cell Non-Hodgkin Lymphoma","2026-06-08",{"date":418,"type":46},{"date":495,"type":46},"2017-04-04",{"date":497,"type":21},"2032-04-01",{"name":499,"class":53},"Mayo Clinic",2,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":54},"100638237","phase-2-research-on-nicotinamide-riboside-supplement-support-in-mds-ross-trial-100638237","NCT07579429","Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)","ROSS","Inclusion Criteria:\n\n* Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Be a male or female aged ≥ 18 years of age.\n* For persons of reproductive potential, use of highly effective method(s) of contraception.\n* Subject must have confirmation of high risk CCUS (defined by CHRS score) or the diagnosis of MDS in the lower risk category as defined by IPSS-M less than 0.\n* Patients must have ECOG of ≤ 2\n* Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.\n* Subject must have adequate liver function as demonstrated by:\n\n  * aspartate aminotransferase (AST) ≤ 3.0 × ULN\n  * alanine aminotransferase (ALT) ≤ 3.0 × ULN\n  * Unless due to Gilbert's syndrome, patients must have a total bilirubin ≤ 3 × ULN.\n* Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.\n\nExclusion Criteria:\n\n* Subject is known to be positive for HIV with uncontrolled disease. HIV testing is not required.\n* Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV may participate.\n* Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his\u002Fher participating in this study including, but not limited to:\n\n  * Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \\> class 2, unstable angina, or myocardial infarction.\n  * Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.\n* Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and\u002For predispose the subject to an increased risk of gastrointestinal toxicity.\n* Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs\u002Fsymptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment.\n* Subject has a history of other malignancies prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the breast or cervix uteri\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\n  * Prostate cancer not requiring therapy beyond hormonal therapy\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent\n* Any subject who is transfusion dependent and a candidate for MDS therapy such as erythroid stimulating agents, thrombopoietin receptor agonists, Lusparercept, Imetelstat or hypomethylating agents.\n* Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening if applicable.\n* Known or suspected hypersensitivity to nicotinamide riboside and pterostilbene.",{"count":509,"type":21},10,[66],"This is an open-label, phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent. There will be two cohorts enrolled at the same time to measure the effect of nicotinamide riboside and pterostilbene at different doses. The primary goals of the study are:\n\n* to assess if study drug improves cytopenias in patients\n* to determine safety of the study drug in patients",[513,30],"Clonal Cytopenia of Undetermined Significance",[515],"Lower Risk Myelodysplastic Syndromes",{"date":517,"type":46},"2026-06-03",{"date":519,"type":46},"2026-05-20",{"date":521,"type":21},"2030-12-18",{"name":182,"class":53},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":530,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":533,"conditions":534,"keywords":538,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":4,"leadSponsor":549,"locationsCount":550},"100125401","collection-of-tissue-samples-for-cancer-research-100125401","NCT00900198","Collection of Tissue Samples for Cancer Research","Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)","* INCLUSION CRITERIA - ADULT:\n* Patients 18 years of age and older who are being evaluated and\u002For treated for cancer at the NIH Clinical Center or at participating sites:\n\n  * Who have a newly diagnosed malignancy for which they have not yet received treatment, or\n  * Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\n\n    * radiographic evidence of tumor growth and\u002For new metastases, or\n    * CBC w\u002Fdifferential and\u002For flow cytometry, or\n    * documented evidence by the treating physician of signs\u002Fsymptoms of clinical disease progression, or\n  * Who are currently undergoing treatment and for whom disease response has not yet been assessed,\n\n    ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.\n  * Patients with ongoing partial response (PR) or stable disease (SD) are eligible.\n\n    * For solid tumor diagnoses, confirmation of viable malignancy and\u002For \\\u003C90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.\n    * For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final flow cytometry report.\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.\n\nAt the NIH Clinical Center ONLY:\n\n* At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and\u002For treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.\n* Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and\u002For treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and\u002For MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.\n\n  * Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.\n\nEXCLUSION CRITERIA:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as but not limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).\n* Patients with invasive fungal infections.\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.\n  * Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible.\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR).\n\nINCLUSION CRITERIA - PEDIATRIC:\n\n* Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.\n* Ability and willingness to assent to participation, utilizing an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission.\n\nAt the NIH Clinical Center ONLY\n\n-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.\n\nEXCLUSION CRITERIA - PEDIATRIC:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics should be completed at least 1 week (7 days) prior to collection\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.\n* Blood only collections from patients with partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.","2 Months",{"count":532,"type":21},5000,"Background:\n\n-Patients who are being evaluated and\u002For treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.\n\nObjectives:\n\n* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.\n* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.\n\nEligibility:\n\n-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and\u002For treated for cancer at the NIH Clinical Center participating sites.\n\nDesign:\n\n* This is a multicenter tissue procurement protocol with NCI as the coordinating center.\n* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.\n* For pediatric patients: tumor biopsy\u002Fresection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.\n* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents\u002Fguardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.\n* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.\n* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.",[535,536,537,30],"Neoplasms","Lymphomas","Multiple Myeloma",[539,540,541,542,543,544],"Tissue Collection","Biospecimen","Assay Development","Tissue Acquisition","Tissue Biopsies","Natural History","2026-05-29",{"date":250,"type":46},{"date":548,"type":46},"2006-07-06",{"name":79,"class":80},17,{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":109,"sex":17,"minAge":558,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":54},"100377523","phase-2-donor-stem-cell-transplant-with-treosulfan-fludarabine-and-total-body-irradiation-for-the-treatment-of-hematological-malignancies-100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n* DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.","6 Months",{"count":560,"type":21},60,[66],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[564,117,28,565,566,567,568,196,121,122,569,570,320,30,571,572,573,574,575],"Acute Leukemia","Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Burkitt Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Lymphoplasmacytic Lymphoma","Mantle Cell Lymphoma","Prolymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma",{"date":545,"type":46},{"date":578,"type":46},"2021-01-25",{"date":580,"type":21},"2029-03-12",{"name":225,"class":53},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":588,"maxAge":190,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":54},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","15 Years",{"count":590,"type":21},100,[66],"This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[594,595,117,596,597,598,599,600,196,601,602,603,604,30,605,606,607,298,215,478,608,609,610,611,612,613],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome",{"date":615,"type":46},"2026-05-22",{"date":617,"type":46},"2016-05-19",{"date":353,"type":21},{"name":305,"class":53},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":54},"100380866","phase-2-a-phase-ii-open-label-study-of-subcutaneous-canakinumab-an-anti-il-1-human-monoclonal-antibody-for-patients-with-low-or-int-1-risk-ipssipss-r-myelodysplastic-syndromes-and-chronic-myelomonocytic-leukemia-100380866","NCT04239157","A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS\u002FIPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.\n* Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.\n* Cohort 4: Diagnosis of CCUS defined as:\n* Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n* Bone marrow aspirate excluding hematological malignancy and MDS\n\n  * Presence of a cytopenia for \\>30 days. Cytopenia will be defined using accepted CHRS (Clonal Hematopoiesis Risk Score) criteria (Weeks et al, NEJM Evidence in press): ANC \\\u003C1.8 or hgb \\\u003C12 in females and \\\u003C13 in males or a platelet count of \\\u003C150.\n* Cohort 1: Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs). These could include azacitidine, decitabine, SGI-110, ASTX727, or CC-486. Patients will need to have received at least 4 cycles of HMA. Participants with relapse or progression after any number of cycles of HMA by IWG 2006 criteria will also be candidates. Participants with evidence of del 5q alteration also are required to have been treated with Lenalidomide.\n* Cohort 1: Hemoglobin \\\u003C10g\u002FdL with symptomatic anemia or transfusion dependency defined as the need for prior transfusion in the past 8 weeks for a hemoglobin level less than 8g\u002Fdl.\n* Cohort 2: Transfusion dependency defined as the need for prior transfusion in the past 8 weeks of (1) at least 2 units of PRBC for a hemoglobin level less than 8g\u002Fdl or symptomatic anemia (hemoglobin \\\u003C10g\u002FdL), or (2) any platelet transfusion.\n* Participants (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or ALT \\\u003C\u002F= 3xULN.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* ECOG performance status \\\u003C\u002F=2.\n\nExclusion Criteria:\n\n* Active infection not adequately responding to appropriate antibiotics.\n* Prior treatment with IL-1\u002FIL-1r inhibitors\n* Absolute neutrophil count (ANC) \\\u003C0.5x109 k\u002Ful; colony-stimulating factors can be administered prior to study drug initiation.\n* Female participants who are pregnant or lactating.\n* Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study. Reproductive potential is defined as no previous surgical sterilization or females that are not post-menopausal for 12 months.\n* Female participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* History of an active malignancy within the past 2 years prior to study entry, with the exception of: a. Adequately treated in situ carcinoma of the cervix uteri b. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin or any other malignancy with a life expectancy of more than 2 years.\n* Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment).\n* Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.\n\nParticipants requiring systemic steroids, methotrexate or other immunosuppressive drugs will not be included in the study.",{"count":627,"type":21},76,[66],"This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.",[196,30,631,216,632,416],"Recurrent Chronic Myelomonocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","2026-05-18",{"date":519,"type":46},{"date":636,"type":46},"2020-08-25",{"date":638,"type":21},"2026-12-31",{"name":305,"class":53}]