[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,359,0,25,[9,51,88,113,137,157,185,205,225,246,266,285,367,387,412,432,455,474,496,517,544,564,592,602,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054019","phase-1-a-study-of-bgb-11417-in-participants-with-myeloid-malignancies-100054019",false,"NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[28,29,30],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[32,33,34,35,36,37],"BGB-11417","Azacitidine","Posaconazole","AML","MDS","MDS\u002FMPN","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2021-05-24",{"date":46,"type":21},"2028-02-08",{"name":48,"class":49},"BeOne Medicines","INDUSTRY",46,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100054010","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100054010","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.","65 Years",{"count":60,"type":21},94,[24],"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).",[64,28,65,66,67,68],"Acute Lymphoid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[70,71,72,73,74,75,76,77],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","NOT_YET_RECRUITING",{"date":41,"type":42},{"date":81,"type":21},"2026-10-31",{"date":83,"type":21},"2030-06-01",{"name":85,"class":86},"University of Arizona","OTHER",1,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100053726","phase-3-xylitol-dental-wipes-for-the-reduction-of-bloodstream-infection-risk-in-children-with-acute-myeloid-leukemia-100053726","NCT07022678","Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia","A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patient must be ≥ 1 year to ≤ 25 years old at enrollment.\n* Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.\n* Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:\n\n  * Contain IV cytarabine (liposomal formulations allowed), and\n  * The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles.\n\nNote: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.\n\n* Minimum of one visible or erupted tooth.\n* Agree to avoid xylitol containing gum or toothpaste during intervention period.\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.\n\nExclusion Criteria:\n\n* Patients with Down syndrome-associated AML.\n* Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.\n* Patients with known history of allergy to xylitol.\n* Patients with known history of allergy to grapes or grape flavoring.\n* Patients who are actively being treated for an oral organism related blood stream infection.\n* Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.","1 Year","25 Years",{"count":98,"type":21},556,[100],"PHASE3","This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.",[28,103],"Recurrent Acute Myeloid Leukemia",{"date":41,"type":42},{"date":106,"type":42},"2026-05-26",{"date":108,"type":21},"2033-01-15",{"name":110,"class":111},"Children's Oncology Group","NETWORK",24,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"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.",{"count":121,"type":21},2000,[25],"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).",[28,125,126,127,66],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic\u002FMyeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemia, Myelodysplasia-Related",{"date":41,"type":42},{"date":130,"type":42},"2024-06-18",{"date":132,"type":21},"2029-05-15",{"name":134,"class":135},"National Cancer Institute (NCI)","NIH",348,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":87},"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":145,"type":21},102,[25],"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.",[28,66],"2026-07-09",{"date":41,"type":42},{"date":152,"type":42},"2025-12-12",{"date":154,"type":21},"2029-08-24",{"name":156,"class":86},"OHSU Knight Cancer Institute",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100053318","phase-1-a-study-to-assess-adverse-events-and-how-intravenous-iv-pivekimab-sunirine-moves-through-the-body-in-pediatric-participants-with-relapsed-or-refractory-acute-myeloid-leukemia-aml-100053318","NCT07306832","A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Must have histologically confirmed acute myeloid leukemia (AML) meeting one of the following disease criteria:\n\n  * Second or greater relapse. OR\n  * Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen).\n* Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.\n* Has \\>= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.\n* Performance status by Lansky (\\\u003C 16 years old at evaluation) or Karnofsky (\\>= 16 years old at evaluation) score \\>= 50 or ECOG score \\\u003C= 2.\n* May have status of central nervous system (CNS)1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome. Participants receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.\n* For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.\n\nExclusion Criteria:\n\n* Known clinically significant cardiac disease.\n* Down syndrome.\n* Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n* Symptomatic central nervous system (CNS3) disease\n* Prior history of any severity veno-occlusive disease\u002Fsinusoidal obstructive syndrome (VOD\u002FSOS) of the liver.\n* Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).\n* Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.\n* Any other known current malignancy requiring therapy.\n* Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.","6 Months","17 Years",{"count":167,"type":21},18,[24],"Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R\u002FR) AML.\n\nPivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.\n\nParticipants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[28],[28,172,173,174,175,176],"Relapsed","Refractory","Pivekimab Sunirine","PVEK","Pediatric",{"date":41,"type":42},{"date":179,"type":42},"2026-05-20",{"date":181,"type":21},"2030-03",{"name":183,"class":49},"AbbVie",8,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":87},"100054222","a-home-based-exercise-intervention-carefit-bmt-in-improving-heart-function-among-patients-with-high-risk-acute-myeloid-leukemia-undergoing-stem-cell-transplant-100054222","NCT07616921","A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant","CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age 18 years or older\n* Ability to understand and willingness to sign a written informed consent document\n* New diagnosis of acute myeloid leukemia at Fred Hutch\n* High-risk patients as defined by one, or more, of the following criteria:\n\n  * Age 65 years or older and\u002For\n  * Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and\u002For\n  * CARE-BMT score ≥ 5\n\n    * Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff\n* Able to exercise at low to moderate intensity, as evaluated by study staff\n* Access to a mobile smart phone\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility\n* Recurrence of AML or diagnosis of other invasive cancer\n* Severe anemia (hemoglobin \\\u003C 7 gm\u002Fdl)\n* History of severe aortic stenosis\n* New York Heart Association (NYHA) class IV heart failure\n* Severe pain with basic movement\n* Pregnant persons\n* Unable to give consent",{"count":193,"type":21},30,[195],"NA","This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a \"prehabilitation\" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.",[28],{"date":41,"type":42},{"date":200,"type":21},"2026-10-01",{"date":202,"type":21},"2028-04-03",{"name":204,"class":86},"University of Washington",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":223,"locationsCount":224},"100540500","phase-2-venetoclax-and-hma-treatment-of-older-and-unfit-adults-with-flt3-mutated-acute-myeloid-leukemia-aml-a-myelomatch-treatment-trial-100540500","NCT06317649","Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)","A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status, age \\> 75 years), organ dysfunction, or disease biology\n* Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11\n* Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible\n* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors\n* Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)\n* Patient must be assigned to this protocol by the myeloMATCH MSRP\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient of childbearing potential and\u002For sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional ULN\n\n  * Either measured or estimated by Cockcroft-Gault equation\n* Creatinine clearance of ≥ 30 mL\u002Fmin\u002F1.73m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration\u002Frandomization are eligible for this trial\n* Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).\n\nNOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02\n\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* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug\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 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\n* Patients must not have an active or uncontrolled infection",{"count":213,"type":21},147,[25],"This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.",[28],"2026-07-01",{"date":219,"type":42},"2026-07-02",{"date":221,"type":42},"2024-09-27",{"date":132,"type":21},{"name":134,"class":135},223,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":87},"100534136","phase-1-study-of-ibr733-cell-injection-in-acute-myeloid-leukemia-100534136","NCT06234904","Study of IBR733 Cell Injection in Acute Myeloid Leukemia","An Open-label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR733 Cell Injection in Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.\n2. Age: 18-74 (both inclusive), female or male.\n3. Patients with AML (including secondary AML) diagnosed according to the WHO 2022 criteria.\n4. Patients with AML who meet one of the following criteria: (1) Relapsed AML: reoccurrence of leukemia cells in peripheral blood or ≥5% blasts in bone marrow after complete remission (excluding other causes such as bone marrow regrowth after consolidation chemotherapy); (2) Refractory AML: treatment-naive patients who failed to respond to 2 courses of standard treatment; The patients relapsed within 12 months after consolidated intensive treatment; Patients who relapsed after 12 months but failed to respond to conventional chemotherapy (only once); Patients who are relapsed twice; (3) Patients received up to 3 additional cycles of chemotherapy or targeted therapy after the diagnosis of relapsed\u002Frefractory AML.\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2.\n6. Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.\n7. Expected survival time ≥3 months.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia.\n2. Chronic myeloid leukemia with myeloid blast crisis.\n3. Clinically symptomatic central nervous system involvement (no need for lumbar puncture).\n4. Subjects who have undergone an allogeneic hematopoietic stem cell transplantation or other organ transplantation.\n5. Subjects who have undergone autologous hematopoietic stem cell transplantation less than 3 months before the first dose of treatment.\n6. Subjects who have received cell immunotherapy such as chimeric antigen receptor-modified T cells (CAR-T), chimeric antigen receptor-natural killer cells (CAR-NK), and T cell receptor gene-modified T cells (TCR-T).\n7. Subjects who have received systemic antitumor therapy (except hydroxyurea) within 2 weeks before the first dose of study drug, including chemotherapy, immunotherapy, etc..\n8. Subjects who have had other malignant tumors within 3 years before inclusion, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.\n9. The absolute peripheral blood blast count (ABC) \\> 40.0×10\\^9\u002FL (ABC= total white blood cell count × blast %). The total white blood cell count can be controlled with hydroxyurea, but it must be stopped three days before the first dose of study drug or lymphodepletion.\n10. Organ function: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\\>3 times upper limit of normal (ULN); If AST was elevated due to leukemia but liver function was normal (e.g., normal ALT, alkaline phosphatase, and direct\u002Findirect bilirubin measurements), participants could be enrolled after investigator consent was obtained; (2) Serum total bilirubin \\>2.5×ULN (not applicable to patients with Gilbert's syndrome); (3) Creatinine clearance \\\u003C45mL\u002Fmin (estimated by Cockcroft-Gault formula) or creatinine \\>2×ULN; (4) Activated partial thromboplastin time \\>1.5×ULN or international normalized ratio \\>1.5×ULN.\n11. Subjects whose cardiac function and disease meet one of the following conditions within 6 months before the first administration: (1) Any risk factors that increase QTcF (Fridericia formula) interval prolongation, such as uncorrectable hypokalemia, hereditary long QT syndrome, and use of drugs that prolong the QTcF interval; (2) New York Heart Association (NYHA) classification ≥Grade 3; (3) Unstable angina pectoris, and myocardial infarction; (4) Left ventricular ejection fraction \\\u003C50% in resting state; (5) Clinically significant pericardial effusion determined by echocardiography.\n12. Subjects who have a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that require systemic immunosuppressive\u002Fsystemic disease modulating drugs within 2 years before the first administration.\n13. Active hepatitis B (e.g., DNA copy number \\> 1000 cps\u002FmL if only hepatitis B surface antigen is positive), active hepatitis C virus infection (anti-hepatitis C antibody positive and HCV RNA positive), or human immunodeficiency virus antibody positive.\n14. Women who are pregnant or lactating.\n15. Subjects who have received major surgery (for the definition of major surgery, refer to the Level 3 and 4 surgeries specified in the Administrative Measures for the Clinical Application of Medical Technology) within 28 days before the first administration.\n16. Subjects who have a history of alcohol, drug use or drug abuse in the past year;\n17. Subjects who have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.\n18. Subjects who are known to be allergic to the main components of the study drug.\n19. Subjects who have other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in the study and receiving the study drug, or may interfere with the interpretation of study results.","74 Years",{"count":167,"type":21},[24],"This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed\u002Frefractory acute myeloid leukemia (AML).",[28],[35,238],"R\u002FR AML",{"date":219,"type":42},{"date":241,"type":42},"2024-03-26",{"date":243,"type":21},"2027-07-01",{"name":245,"class":49},"Imbioray (Hangzhou) Biomedicine Co., Ltd.",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},"100481851","phase-2-comparing-cytarabine--daunorubicin-therapy-versus-cytarabine--daunorubicin--venetoclax-versus-venetoclax--azacitidine-in-younger-patients-with-intermediate-risk-aml-a-myelomatch-treatment-trial-100481851","NCT05554393","Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)","A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH SubStudy","Inclusion Criteria:\n\n* Patient must have enrolled onto MYELOMATCH and must have been given a treatment assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an actionable mutation as defined in MYELOMATCH\n* Participants must have been registered to master screening and re-assessment protocol (myeloMATCH MSRP) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine (MRD) and must be offered the opportunity to submit biosamples for banking for future research as per the myeloMATCH MSRP\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under the MSRP\n* Previously untreated, de novo acute myeloid leukemia (AML) defined by \\> 20% myeloblasts in the peripheral blood or bone marrow (refer to the 2016 updated World Health Organization \\[WHO\\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:\n\n  * Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11\n  * CEBPA biallelic mutations\n  * NPM1 mutation\n  * AML with PML-RARalpha\n  * AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23\u002FKMT2 rearrangements\n  * AML with FLT3-ITD or FLT3-TKD mutations\n  * Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease\n* Age 18-59 years at time of induction therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (must be done within 7 days of enrollment)\n* Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \\[SGPT\\]) +\u002For alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3 × institutional ULN (must be done within 7 days of enrollment)\n* Cardiac ejection fraction \\>= 50% (echocardiography or multigated acquisition scan \\[MUGA\\]) (if clinically indicated must be done within 14 days of enrollment)\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin\u002F 1.73m\\^2; Clearance to be calculated using Cockcroft formula (must be done within 7 days of enrollment)\n* White blood cells (WBC) must be \\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped at least 24 hours prior to the initiation of protocol therapy. 1 dose of cytarabine at 1 mg\u002Fm\\^2 for urgent cytoreduction is also permitted\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 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\n* Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures.\n\nWomen of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy\n\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n\nPatients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial\n\n* In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment\n* Participants receiving strong or moderate CYP3A inhibitors must agree to discontinue use at least 48 hours prior to start of study treatment if assigned to arm 1 or 2\n* Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible\n\nExclusion Criteria:\n\n* Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax\n* Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have 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 venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study\n* Patients with isolated myeloid sarcoma are not eligible\n* Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):\n\n  * Active, uncontrolled bacterial, fungal, or viral infection","59 Years",{"count":255,"type":21},153,[25],"This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.",[28],{"date":219,"type":42},{"date":261,"type":42},"2024-09-13",{"date":263,"type":21},"2027-12-31",{"name":134,"class":135},178,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100481852","phase-2-testing-the-effects-of-novel-therapeutics-for-newly-diagnosed-untreated-patients-with-high-risk-acute-myeloid-leukemia-a-myelomatch-treatment-trial-100481852","NCT05554406","Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)","A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial","Inclusion Criteria:\n\n* STEP 1 REGISTRATION:\n* Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under MYELOMATCH\n* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria\n* Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria\n* Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible\n* Acute promyelocytic leukemia is excluded\n* Participants with favorable or intermediate risk disease are excluded\n* Participants with FLT3 mutations (ITD or TKD) are excluded\n* Participants with t(9;22) translocation are excluded\n* A single dose of intrathecal chemotherapy is allowed prior to study entry\n* Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg\u002Fm\\^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis\n* Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed.\n* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy\n* Participants must be between 18 and 59 years of age\n* Participants must have Zubrod performance status =\\\u003C 3 as determined by a history and physical (H\\&P) completed within 14 days prior to registration\n* Participants must have a complete medical history and physical exam within 7 days prior to registration\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration\n* The following tests must be performed within 14 days prior to registration to establish baseline values:\n\n  * Complete blood count (CBC)\u002Fdifferential\u002Fplatelets\n  * Total bilirubin\n  * Lactate dehydrogenase (LDH)\n  * Albumin\n  * Glucose\n  * Fibrinogen\n* Participants must have adequate kidney function as evidenced by creatinine clearance \\>= 30mL\u002Fmin (by Cockcroft Gault) within 28 days prior to registration\n* Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3.0 x upper limit of normal (ULN) within 28 days prior to registration\n* Total bilirubin =\\\u003C 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration\n* Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \\>= 50% within 28 days prior to registration\n* Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy\n* Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded\n* Participants must not be pregnant or nursing. Women\u002Fmen of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \\[examples include birth control pills, vaginal rings, or patches\\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown\n* Participants must have agreed to have specimens submitted for translational medicine (MRD) under the myeloMATCH MSRP and specimens must be submitted\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* 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",{"count":274,"type":21},335,[25],"This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. \"High-risk\" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.",[28,125,126,127],{"date":219,"type":42},{"date":280,"type":42},"2024-09-25",{"date":282,"type":21},"2027-03-31",{"name":134,"class":135},221,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":292,"sex":17,"minAge":293,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years","75 Years",{"count":121,"type":21},"OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[299,28,300,301,302,303,304,67,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358],"Acute Lymphoblastic Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":219,"type":42},{"date":361,"type":42},"2022-08-18",{"date":363,"type":21},"2027-02-28",{"name":365,"class":86},"Alliance for Clinical Trials in Oncology",745,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":87},"100616315","phase-2-olutasidenib-with-azacitidine-followed-by-olutasidenib-maintenance-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-in-patients-with-prior-treatment-with-venetoclax-plus-a-hypomethylating-agent-100616315","NCT07304011","Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent","A Phase 2 Study of Olutasidenib in Combination With Azacitidine Followed by Olutasidenib Maintenance After Venetoclax Plus a Hypomethylating Agent Regimen (HMA-VEN) for IDH1-Mutated Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Pathologically documented AML (except acute promyelocytic leukemia with the t(15;17) translocation) as defined by the World Health Organization (WHO) or International Consensus Classification criteria\n* Achieved complete response (CR)\u002Fcomplete remission with incomplete count recovery (CRi) response to first line HMA-Ven according to the European Leukemia Net (ELN) recommendations for diagnosis as determined by investigator review\n* Documented IDH1-R132 mutations (≥ 0.01%) detected in the bone marrow or blood. Mutation must be present at the time of AML diagnosis or after initiating HMA-Ven\n* Receiving first-line HMA-Ven with less than or equal to 4 cycles of HMA-Ven at the time of enrollment. Participants must discontinue venetoclax (Ven) at least 1 week (or 5 half-lives, whichever is shorter) from initiating study treatment\n* Candidate for standard of care azacitidine\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* No prior solid organ allograft\n* Recovery from the non-hematologic toxic effects of prior treatment to grade ≤ 1, or baseline value according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) classification (excluding infertility or alopecia)\n* Aged ≥ 18 at the time of consent\n* Creatinine clearance ≥ 40 mL\u002Fmin (calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection)\n* Serum alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Serum aspartate aminotransferase (AST) ≤ 3 × ULN\n* Bilirubin ≤ 2 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)\n\n  * Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is ≤ 2 × ULN\n* Prothrombin time (PT) or international normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Women of child-bearing potential, men, and their respective partners, must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose of olutasidenib\n* Must sign and date the informed consent form prior to undergoing any study procedures\n\nExclusion Criteria:\n\n* Prior IDH1 inhibitor (IDH1i) targeted therapy\n* Prior AML therapy except for HMA-Ven\n* History of a different malignancy unless they have been disease-free for at least 12 months and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with a history of other malignancies within 12 months and without any evidence of disease progression or requiring therapy may be considered, but only after consideration and approval by the Overall Principal Investigator (PI). Individuals with the following cancers are eligible if diagnosed and\u002For treated within the past 12 months: cervical cancer in situ, breast ductal carcinoma in situ (DCIS), and basal cell or squamous cell carcinoma of the skin\n* Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy\n* Patients with previous allogeneic hematopoietic stem cell transplantation (HSCT) for non-AML indications, if they meet any of the following criteria: \\\u003C 100 days from time of HSCT; active acute or chronic graft versus (vs.) host disease (GvHD); or receiving immunosuppressive therapy as treatment or prophylaxis against GvHD\n\n  * Note: Doses \\\u003C 20 mg methylprednisolone (or its equivalent) daily are not an exclusion criterion\n* Treatment with radiation therapy or major surgery (requiring general anesthesia) within 2 weeks prior to study drug dosing\n* Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption\n* Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias\n* Patients with a baseline corrected QT interval by Fridericia's formula (QTcF) of \\> 480 msec\n\n  * Note: This criterion does not apply to patients with a bundle branch block (BBB); for participants with BBB, a cardiology consult is recommended to ensure that QTcF is not prolonged\n* Concomitant medication(s) known to cause Torsades de Pointes (TdP) initiated less than the duration required to reach steady-state plasma concentration (approximately five half-lives) before first dose of study drug. Medications used as needed (PRN), e.g. Zofran, and common AML supportive care drugs (e.g. levofloxacin, azoles, etc.) are exempt\n* Concurrent treatment with chronic corticosteroids except if chronic treatment with \\\u003C 20 mg of methylprednisolone daily or equivalent (pulse steroids for treatment or prophylaxis are allowed \\[e.g., for transfusion or medication reactions\\])\n* Known history of seropositivity for HIV infection\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy (prophylactic systemic antimicrobials permitted)\n* Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia)\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 90 days after the last dose of olutasidenib. Pregnant or breastfeeding\n\n  * NOTE: Breast milk cannot be stored for future use while the mother is being treated on study)\n* Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 90 days after the last dose of olutasidenib\n* Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care\n* Medical, uncontrolled disease-related metabolic disorder, psychiatric, cognitive, or other conditions that may, in the opinion of the investigator, compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study",{"count":375,"type":21},28,[25],"This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.",[28],"2026-06-30",{"date":219,"type":42},{"date":382,"type":42},"2025-12-17",{"date":384,"type":21},"2029-12-01",{"name":386,"class":86},"University of California, Davis",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":292,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":407,"leadSponsor":409,"locationsCount":411},"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).",{"count":50,"type":21},[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.",[398,299,28,304,399,400,401,402,66,403,404,68],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelofibrosis","Myeloproliferative Neoplasm",{"date":219,"type":42},{"date":379,"type":42},{"date":408,"type":21},"2028-05-30",{"name":410,"class":86},"City of Hope Medical Center",3,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":87},"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":420,"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.",[28,424,66],"Graft Versus Host Disease","2026-06-29",{"date":217,"type":42},{"date":428,"type":42},"2026-06-12",{"date":430,"type":21},"2027-05-25",{"name":410,"class":86},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100347357","phase-1-a-phase-1-study-of-orca-q-in-recipients-undergoing-allogeneic-transplantation-for-hematologic-malignancies-100347357","NCT03802695","A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies","Key Inclusion Criteria:\n\n1. Age at the time of enrollment:\n\n   1. For MAC with fully matched donor (Arm A with 8\u002F8 donor and Arm C) and NMA\u002FRIC: Age ≥ 12 and ≤ 78 years\n   2. For MAC with mismatched donors (Arm A with 7\u002F8 donor and Arm B): Age ≥ 12 and ≤ 65 years\n2. Diagnosed acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM)\n3. Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)\n4. Matched to a 8\u002F8 or 7\u002F8 related or unrelated donor, or to a related haploidentical donor\n5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fminute (MAC with tacrolimus) or \\> 30 mL\u002Fminute (NMA\u002FRIC or MAC without tacrolimus)\n6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA\u002FRIC)\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA\u002FRIC\n8. Liver function: Total bilirubin \\\u003C 1.5 times upper limit of normal (ULN) (MAC) or \\\u003C 3 times ULN (NMA\u002FRIC); alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C 3 times ULN (MAC) or \\\u003C 5 times ULN (NMA\u002FRIC)\n9. Participants enrolling on NMA\u002FRIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)\n\nKey Exclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy except for approved disease-specific therapy for the patient's underlying hematologic malignancy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab\n5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor\n6. Low performance score: For MAC: Karnofsky Performance Score (KPS) \\\u003C 70 percent, For NMA\u002FRIC: \\\u003C60 percent\n7. High HCT-specific Comorbidity Index (HCT-CI): For MAC \\> 4, For NMA\u002FRIC \\>6\n8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment\n9. Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab)\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected. Patients with concurrent indolent hematologic malignancies that do not require active treatment and are under active surveillance only (such as CLL, low-grade lymphomas, smoldering MM, MZL) may be included with the approval of Medical Monitor\n12. History of idiopathic or secondary myelofibrosis\n13. Women who are pregnant or breastfeeding","12 Years","78 Years",{"count":442,"type":21},300,[24],"This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts (\"OrcaGraft\"\u002F\"Orca-Q\") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.",[28,29,446,299],"Mixed Phenotype Acute Leukemia",{"date":217,"type":42},{"date":449,"type":42},"2019-04-08",{"date":451,"type":21},"2027-12",{"name":453,"class":49},"Orca Biosystems, Inc.",12,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":87},"100543539","phase-1-iadademstat-in-combination-with-azacitidine-and-venetoclax-in-treating-newly-diagnosed-acute-myeloid-leukemia-100543539","NCT06357182","Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia","A Phase Ib Investigation of the LSD1 Inhibitor Iadademstat (ORY-1001) in Combination With Azacitidine and Venetoclax in Newly Diagnosed AML","Inclusion Criteria:\n\n* Patients at least 18 years of age will be considered for inclusion without bias against gender identity, race, or ethnicity\n* Ability to comprehend the investigational nature of the study and provide written informed consent\n* Patients with previously untreated, morphologically documented AML based on World Health Organization (WHO) 2008 definitions who are ineligible for standard of care (SOC) intensive chemotherapy (IC) induction OR documented unwillingness to undergo IC induction. Ineligible for IC is defined as:\n\n  * Documented intermediate- or adverse-risk AML based on European Leukemia Network (ELN) 2022 criteria\n  * Note: Cases of AML (MDS) overlap with 10-19% bone marrow (BM) or peripheral blood (PB) blasts will be considered\n  * Note: Cases of acute promyelocytic leukemia (PML) and AML with BCR::ABL1 fusions will be excluded\n* Eastern Cooperative Oncology Group (ECOG) performance ≤ 2 (Patients aged ≥ 75 years, at the time of consent)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients aged ≥ 75 years, at the time of consent)\n\n  * High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin\n* Creatinine clearance (CrCl) of ≥ 60 mL\u002Fmin (estimated using the Cockcroft Gault formula or measured by 24 hours urine collection. If altered, CrCl is determined to be related to concomitant medication that alters renal function\n* Patients aged ≥ 18 to 74 years (ECOG performance status \\[PS\\] ≤ 3 is accepted) at consent must meet ≥ 1 of the following criteria defining a co morbidity:\n\n  * ECOG PS of 2 or 3 (Note: Patients ≥ 18 to 74 years of age with PS of 0-1 must meet criteria of one of the following comorbidities.)\n  * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n  * Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%\n  * CrCl ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n  * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × ULN;\n\n    * High total bilirubin values may require indirect and direct bilirubin testing. Individuals with known Gilbert's syndrome may be considered for enrollment despite high indirect (and total) bilirubin\n  * Other comorbidities that the physician judges to be incompatible with intensive chemotherapy (IC). In these cases, the comorbidity must be reviewed and approved by the principal investigator (PI) before study enrollment\n* Ability to swallow oral medications\n* No ongoing anticoagulation or antiplatelet therapy within 14 days of start of treatment with IADA\n* No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* No history of stroke or intracranial hemorrhage within 180 days of start of IADA\n* No major bleeding event, as defined by the International Society of Thrombosis and Hemostasis (ISTH), within 12 weeks of start of IADA\n* Uncorrected international normalized ratio (INR) or activated partial thromboplastin time (aPTT) of \\\u003C 1.5 x ULN.\n\n  * If INR or aPTT \\> 1.5 x ULN has been corrected (prior to enrollment), then history of disseminated intravascular coagulation (DIC) must be absent\n* White blood cell (WBC) \\\u003C 20 x 10\\^9\u002FL prior to study start. Cytoreduction prior to study treatment is allowed with\n\n  * Hydroxyurea for up to 14 days and until 24 hours prior to start of IADA; or\n  * Leukapheresis for up to 14 days prior to start of IADA\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.0 x institutional ULN\n\n  * Lower hepatic function may be considered if liver enzyme abnormalities are determined by the treating MD and principal investigator (PI) to be due to leukemic infiltration\n* Willing and able to\n\n  * Adhere to study schedule of activities and life style 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 72 hours of start of IADA for persons of childbearing potential (PCBP)\n* Willingness to comply with study requirements for contraception, as follows: PCBP and sperm-producing participants who are sexually active with a PCBP must use study approved contraception from start of investigational product (first dose of IADA) until 6 months after the last dose of IADA. Pregnancy is exclusionary because the agents used in this study have the potential for teratogenic or abortifacient effects\n\nExclusion Criteria:\n\n* Prior allergic response to iadademstat (IADA), venetoclax, azacitidine, or any excipients in the formulations\n* Body weight \\\u003C 50 kg\n* Investigational therapy within 5 half-lives or, if unknown, within 28 days prior to start of IADA\n* Treatment for AML within 14 days prior to start of IADA. Cytoreduction for patients with proliferative disease must meet the criteria listed in inclusion criteria\n* Radiotherapy less than 14 days prior to start of IADA\n* Recent and significant medical interventions, such as major surgery within 28 days prior to the start of IADA, or stem cell transplant within 100 days prior to the start of IADA. Patients with active treatment for graft-versus-host disease (GVHD) are excluded\n* Another active malignancy within 5 years prior to the start of IADA, or at the investigator's discretion\n* Treatments targeting or inhibiting LSD1\u002FKDM1A or BCL 2 within 12 months prior to the start of IADA\n* Documented dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally\n* Treatment with monoamine oxidase inhibitors (e.g., tranylcypromine), if treatment is not finalized at least 3 weeks prior to the start of IADA\n* Active central nervous system involvement with AML\n* Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to start of IADA and must be amenable to alternate treatment if current treatment will interact with investigational regimen\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 IADA. (Hepatitis B or C testing is not required for eligibility assessment.)\n* Individuals serology positive for human immunodeficiency virus (HIV) and under active treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents). Otherwise, enrollment may be considered in cases of HIV that is controlled with another treatment type or in cases that that acceptable modification of the patient's HIV treatment exists\n* Use a P-gp inhibitor within 21 days or 3 half-lives whichever is longer prior to treatment with venetoclax\n* Use of strong or moderate CYP3A4 inducers or inhibitors within 2 days or 3 half lives whichever is longer, prior to start of treatment with venetoclax\n* Unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided throughout the study and until at least 60 days after last dose of IADA\n* Uncontrolled hypertension (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg). Use of anti-hypertensive agents to control hypertension before C1D1 is allowed\n* Patients with poorly controlled diabetes. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) ≥ 8%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion\u002Fexclusion criteria are met\n* Patients with mean of triplicate corrected QT interval (Fridericia's correction formula \\[QTcF\\]) \\> 450 ms at Screening based on central reading\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, unstable cardiac or pulmonary function or acute insufficiency (e.g., symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), or psychiatric illness or social situation that could limit compliance with study requirements, at the discretion of the investigator",{"count":193,"type":21},[24],"This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, 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 iadademstat with azacitidine and venetoclax may be safe, tolerable and\u002For effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.",[28,466],"Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-28",{"date":379,"type":42},{"date":470,"type":42},"2024-08-22",{"date":472,"type":21},"2028-05-29",{"name":156,"class":86},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":479,"conditions":484,"keywords":485,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100410708","phase-3-phase-iii-study-of-induction-and-consolidation-chemotherapy-with-venetoclax-in-patients-with-newly-diagnosed-aml-or-mds-eb-2-100410708","NCT04628026","Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2","A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2","Inclusion Criteria:\n\n1. Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).\n2. Age ≥ 18 and ≤ 75 years.\n3. Patients considered eligible for intensive chemotherapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Molecular analysis centrally performed in AMLSG and HOVON laboratories.\n6. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>40 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n7. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators.\n8. No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \\[WBC\\] counts \\> 25x109\u002FL); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.\n9. Patients must not have received a known strong or moderate CYP3A inducer 7 days before start of study treatment. Patients must have no known medical conditions requiring chronic therapy with moderate or strong CYP3A inducers.\n10. Female patient must either:\n\n    * Be of nonchildbearing potential:\n\n      * Postmenopausal (defined as at least 1 year without any menses)\n      * Documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening)\n    * Or, if of childbearing potential (not surgically sterile and not postmenopausal)\n\n      * Not planning to become pregnant during the study and for 6 months after the final study drug administration\n      * And have a negative urine or serum pregnancy test at screening\n      * And, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration\n\n        \\*Highly effective forms of birth control include\n      * Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \\[estrogen and progestogen containing\\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.\n      * Established intrauterine device (IUD) or intrauterine system (IUS)\n      * Bilateral tubal occlusion\n      * Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n      * Male is sterile due to a bilateral orchiectomy.\n      * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.\n\n        \\*List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.\n      * Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.\n      * Female patient must not donate ova starting at screening and throughout the study period, and for 27 weeks after the final study drug administration.\n11. Men must use a latex condom during any sexual contact with WOCBP, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 27 weeks after the final study drug administration). In addition, their female partners of childbearing potential have to use a highly effective method of birth control.\n12. Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration.\n13. Able to understand and willing to sign an informed consent form (ICF).",{"count":482,"type":21},650,[100],[28],[486],"adult patients","2026-06-26",{"date":379,"type":42},{"date":490,"type":42},"2022-09-13",{"date":492,"type":21},"2032-02",{"name":494,"class":86},"University of Ulm",91,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":87},"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":505,"type":21},35,[25],"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.",[299,28,509,424,66,404],"Chronic Myelomonocytic Leukemia","2026-06-25",{"date":425,"type":42},{"date":513,"type":42},"2025-04-18",{"date":515,"type":21},"2028-10-15",{"name":410,"class":86},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":532,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":87},"100633571","phase-2-evaluation-of-antibiotic-prophylaxis-in-myelodysplastic-syndromes-and-acute-myeloid-leukemia-myelo-canabx-100633571","NCT07528417","Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)","Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial","MYELO-CAN:ABX","Inclusion Criteria:\n\nMaster platform inclusion criteria:\n\n1. Age ≥ 18 years\n2. Diagnosis of myelodysplastic syndrome, myelodysplastic\u002Fmyeloproliferative neoplasm, or acute myeloid leukemia\n\nMYELO-CAN ABX inclusion criteria:\n\n1\\. Initiation of hypomethylating agent-based chemotherapy\n\nExclusion Criteria:\n\nMaster platform exclusion criteria:\n\n1. Participant is deemed unlikely to survive \\>30 days (as determined by clinical team)\n2. Participant unable to provide informed consent\n\nMYELO-CAN ABX exclusion criteria:\n\n1. Fever\u002Finfection within 1 month of chemotherapy initiation\n2. C-difficile infection within 12 months of chemotherapy initiation\n3. Known sensitivity\u002Fallergy to fluoroquinolones\n4. History of tendon disorders related to fluoroquinolone administration\n5. Seizure disorder\n6. Myasthenia gravis\n7. Pregnancy and\u002For breastfeeding",{"count":526,"type":21},75,[25],"Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life-changing blood cancers. Patients with MDS and AML commonly experience complications related to infection, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of levofloxacin (antibiotic) in MDS and AML patients to safely reduce the risk of infection. In this study 50% of patients will be randomized (like a flip of a coin) to receive levofloxacin and the other 50% will receive usual care (control). The primary objective of the trial is to demonstrate the feasibility of a pragmatic pilot trial necessary to inform our planned phase 3 trial. Additionally, the investigators will monitor both groups of patients to see if the investigators improve the risk and\u002For severity of infection. Levofloxacin is commonly used in other clinical settings but has not been studied in patients with MDS or AML receiving outpatient chemotherapy (ie, chemotherapy that can be given from clinic, rather than a hospital).",[530,531,28],"Myeldysplastic Syndrome (MDS)","MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)",[533,534,66,404,28,535],"Levofloxacin","Randomized Controlled Trial","Neutropenia","2026-06-24",{"date":425,"type":42},{"date":539,"type":21},"2026-09-01",{"date":541,"type":21},"2028-04-30",{"name":543,"class":86},"University of Manitoba",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":87},"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":552,"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.",[28,66,103,556],"Recurrent Myelodysplastic Syndrome",{"date":487,"type":42},{"date":559,"type":42},"2024-09-23",{"date":561,"type":21},"2028-10-01",{"name":563,"class":86},"Fred Hutchinson Cancer Center",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":579,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":590,"locationsCount":87},"100644306","phase-2-study-on-the-efficacy-and-safety-of-va-regimen-compared-to-37-regimen-in-newly-diagnosed-aml-with-npm1-or-idh1idh2-mutations-100644306","NCT07664839","Study on the Efficacy and Safety of VA Regimen Compared to \"3+7\" Regimen in Newly Diagnosed AML With NPM1 or IDH1\u002FIDH2 Mutations","A Prospective, Multicenter, Randomized Controlled, Open Label, Non-Inferiority Study Comparing the Efficacy and Safety of the VA Regimen (Venetoclax Combined With Azacitidine) With the \"3+7\" Regimen in the Treatment of Newly Diagnosed AML Patients With NPM1 or IDH1\u002FIDH2 Mutations","Inclusion Criteria:\n\n* Age ≥ 65 years old ≥ 18 years old;\n* Diagnosed as acute myeloid leukemia (non APL) (diagnostic criteria refer to the 2022 ELN classification system);\n* Initial diagnosis accompanied by NPM1 mutations (A, B, D types and rare types are all acceptable) and\u002For IDH1\u002FIDH2 mutations;\n* Have not received any other induction therapy before (except hydroxyurea);\n* Physical fitness status score (ECOG PS) 0-3;\n* Having sufficient organ function, defined as follows:\n\n  1. Liver function: serum total bilirubin ≤ 3 x upper limit of normal range (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 x ULN, unless considered to be caused by leukemia;\n  2. Renal function: endogenous creatinine clearance rate ≥ 30ml\u002Fmin;\n  3. Heart function: NYHA classification ≤ 2 points;\n* Participants must have the ability to understand and be willing to participate in this study, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia;\n* Merge extramedullary infiltration such as central nervous system leukemia;\n* Have a clear history of CMML or MDS, and later progress to AML; Or have a history of malignant tumors;\n* There is uncontrolled active infection (including bacterial, fungal, or viral infections);\n* Pregnant or lactating women;\n* Researchers determine that participants are not suitable to participate in this experiment",{"count":572,"type":21},148,[25],"This prospective, multicenter, randomized, open-label, non-inferiority clinical study aims to compare the efficacy and safety of VA regimen (venetoclax combined with azacitidine) versus conventional \"3+7\" chemotherapy regimen in adult patients aged 18 to 65 years with newly diagnosed acute myeloid leukemia (AML) carrying NPM1, IDH1 or IDH2 gene mutations.\n\nThe primary goal of this trial is to check whether the VA treatment can reach a non-inferior composite complete remission rate at the end of the induction treatment cycle, which is the key primary endpoint of this research. Several secondary clinical outcomes will also be evaluated in this study, including the rate of minimal residual disease (MRD) negativity after remission, duration of remission, 1-year event-free survival rate and 1-year overall survival rate of enrolled patients. In addition, the safety and treatment-related side effects occurring during the whole induction treatment phase will be systematically collected and compared between two groups as another important secondary assessment.\n\nEligible enrolled participants will be randomly split into two study groups: patients in experimental group will receive venetoclax plus azacitidine (VA regimen), while patients in control group will receive standard \"3+7\" induction chemotherapy following conventional clinical protocol. All subjects will complete regular disease assessment, laboratory examinations and scheduled follow-up visits as required by trial design during treatment and post-treatment observation period.\n\nResearchers will collect and analyze all above clinical outcome data from all participants, to verify the non-inferior efficacy and relative safety of VA regimen for this specific subtype of newly diagnosed AML patients.",[28,576,577,578],"NPM1 Mutation","IDH1 Mutation","IDH2 Mutation",[580,581,582,583,584],"Acute myeloid leukemia","Venetoclax","NPM1 mutation","IDH1 mutation","IDH2 mutation","2026-06-23",{"date":536,"type":42},{"date":217,"type":21},{"date":589,"type":21},"2032-05-31",{"name":591,"class":86},"Shen yang",{"id":593,"slug":4,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":595,"briefSummary":123,"conditions":596,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":600,"locationsCount":601},"100482619",{"count":121,"type":21},[25],[28,125,126,127,66],{"date":536,"type":42},{"date":130,"type":42},{"date":132,"type":21},{"name":134,"class":135},347,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":637,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":87},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":442,"type":21},[25],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[614,28,299,615,616,617,618,403,619,620,621,304,622,623,624,625,626,627,628,402,629,630,631,632,633,634,635,636],"Acute Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[35,17,36,638,639,640,641],"NHL","CLL","CML","SLL",{"date":510,"type":42},{"date":644,"type":42},"2018-03-30",{"date":646,"type":21},"2028-06-10",{"name":648,"class":86},"Masonic Cancer Center, University of Minnesota",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":22,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":87},"100538058","phase-1-phase-i-study-of-hc-7366-for-acute-myeloid-leukemia-100538058","NCT06285890","Phase I Study of HC-7366 for Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Patients need to have a confirmed diagnosis of AML, or MDS\u002FAML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.\n\n   Dose escalation phase\n2. Patients ≥18 years with R\u002FR AML or R\u002FR MDS\u002FAML, other than acute promyelocytic leukemia (APL), with no available standard treatment options.\n3. Relapsed or refractory disease defined by standard criteria as follows:\n\n   a. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR\u002FCRi\u002FMLFS b. Refractory: Failure to achieve CR\u002FCRi\u002FMLFS following initial treatment, with evidence of persistent leukemia by blood and\u002For bone marrow evaluation with blasts ≥5% c. Appropriate prior therapy in order for patient to be deemed relapsed or refractory include any of the following: i. At least 1 cycle of purine analogue containing intensive induction chemotherapy regimen, e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax.\n\n   ii. At least 1 cycle of intensive induction chemotherapy with venetoclax, e.g., 7 + 3 or CPX-251 with venetoclax or similar regimens iii. At least 2 cycles of intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax iv. 2 cycles of venetoclax with HMA\u002FLDAC +\u002F- other agents v. 4 cycles of HMA alone d. Younger\u002Ffit patients in first relapse following intensive chemotherapy, will only be eligible if the first remission (CR1) duration was ≤12 months.\n\n   e. Participants relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration.\n\n   f. Older\u002Funfit patients who relapse on HMA + venetoclax based maintenance regimen will be eligible irrespective of CR1 duration\n4. ECOG PS 0 to 2\n5. Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic (\"replacement\") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.\n6. Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1\u002F2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.\n7. Patients with antecedent hematological disorder (AHD), e.g., aplastic anemia, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or myeloproliferative disorder or neoplasm (MPD or MPN) who have previously received a regimen appropriate for AML for the antecedent hematological disorder, as described above, and have progressed to AML, will be eligible for the dose escalation phase. This is due to recognized poor outcomes in such patients with \"treated secondary AML\".\n\n   All Participants\n8. Adequate hepatic function (total bilirubin ≤1.5 x upper limit of normal (ULN) unless increase is due to Gilberts's disease or leukemic involvement, and AST and\u002For ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and\u002For ALT ≤ 3 x ULN will be considered eligible).\n9. Adequate renal function with creatinine clearance ≥ 45 mL\u002Fmin calculated by the Cockcroft-Gault formula or MDRD equation or measured by 24-hour urine collection.\n10. The effects of these agents on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after last treatment.\n\n    a. This includes all female participants between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n    ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy).\n\n    iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    b. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n\n    c. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with t(15;17) karyotypic abnormality.\n2. Patient has a white blood cell count \\> 15 x 10⁹\u002FL. Hydroxyurea, and\u002For cytarabine (up to 2 g\u002Fm2 total) used as supportive care is permitted to meet this criterion.\n3. Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.\n4. Patients with known symptomatic or uncontrolled CNS leukemia.\n5. Patient has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate treatment.\n6. Patients with any severe gastrointestinal or metabolic condition which could interfere with absorption of oral study medications or history of chronic diarrhea, enteritis, colitis, inflammatory bowel disease, irritable bowel syndrome. Patients with remote history of such events may be allowed based on review and discussion with PI.\n7. Active and uncontrolled comorbidities including decompensated congestive heart failure NYHA class III\u002FIV, clinically significant, uncontrolled arrhythmia, acute respiratory failure, unstable or decompensated pulmonary disease, as judged by the treating physician.\n8. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection.\n9. Decompensated congestive heart failure, hypokalemia, prolonged QT interval corrected for heart rate (QTc) (as calculated using Fridericia's formula) to greater than 450 msec for males, or to greater than 470 msec for females or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and\u002For cardiologist.\n\n11\\. Any previous malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and\u002For surgery and\u002For radiotherapy at least 1 month prior to enrollment. Patients having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination or imaging or cytology\u002Fpathology, e.g., non-melanoma skin cancers, or any carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.\n\n12\\. Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.\n\n13\\. Patients under legal protection measure (guardianship, trusteeship or safeguard of justice) and\u002For uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, inability, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.\n\n14\\. A known hypersensitivity or severe allergy to study drug components or diluents.\n\n15\\. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.\n\n16\\. Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.\n\n17\\. The study will exclude first-degree relatives of the investigator, study staff or industry sponsor.",{"count":167,"type":21},[24],"To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.",[28],"2026-06-22",{"date":536,"type":42},{"date":662,"type":42},"2024-05-20",{"date":664,"type":21},"2029-12-31",{"name":666,"class":86},"M.D. Anderson Cancer Center"]