[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloproliferative-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloproliferative-neoplasm":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,49,0,25,[9,43,67,99,128,151,176,202,222,246,265,293,312,351,379,391,415,453,493,518,547,571,591,611,631],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053480","evaluation-of-the-pathobiology-of-calr-mutated-mpn-cells-100053480",false,"NCT06480591","Evaluation of the Pathobiology of CALR-mutated MPN Cells","Inclusion Criteria:\n\n* Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his\u002Fher legally authorized representative (LAR).\n* Age ≥ 18 years at the time of enrollment\n* Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS\u002FMPNs\n* CALR-positive genetic mutation\n\nExclusion Criteria:\n\n\\- Diagnosis of MPN with JAK2 V617F mutation",true,"ALL","18 Years",{"count":20,"type":21},35,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.",[25],"Myeloproliferative Neoplasm",[27,28,29],"Thrombosis","JAK2 mutation","CALR mutation","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-01-21",{"date":38,"type":21},"2027-09",{"name":40,"class":41},"Wake Forest University Health Sciences","OTHER",2,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100645055","phase-1-phase-i-trial-of-pacritinib-in-combination-with-venetoclax-and-azacitidine-for-the-treatment-of-accelerated-and-blast-phase-myeloproliferative-neoplasms-100645055","NCT07679334","Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Subjects must have accelerated phase MPN as defined by 10-19% blasts or blast phase MPN (AML) as defined by ≥ 20% blasts in the blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, with a documented prior diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or primary myelofibrosis (PMF), The absence of a spleen, lack of splenomegaly, or history of splenic irradiation is not exclusionary.\n* Subjects with blast phase MPN must be newly diagnosed\u002Funtreated (no prior blast reduction therapy for blast phase disease except for hydroxyurea and\u002For a JAK inhibitor; treatment of a prior accelerated phase is allowed). Prior treatment with a hypomethylating agent (with or without a JAK inhibitor) is allowed for accelerated phase MPN. Prior treatment with any JAK inhibitor (including pacritinib) is allowed for any phase of disease (chronic, accelerated, or blast); however, must not have discontinued pacritinib due to toxicity. If a participant previously required dose reduction during pacritinib therapy and tolerated it well, then may enroll into a cohort utilizing that dose level or lower.\n* WBC \\\u003C 25 x 109\u002FL prior to treatment initiation- subjects with WBC ≥ 25 x 109\u002FL may still be eligible after receiving cytoreduction measures such as hydroxyurea and\u002For leukapheresis if WBC becomes \\\u003C 25 x 109\u002FL prior to treatment initiation. Cytoreduction with hydroxyurea and\u002For leukapheresis is allowed prior to treatment. Hydroxyurea must be discontinued ≥ 12 hours prior to treatment initiation.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration:\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) unless considered to be due to Gilbert's Syndrome, hemolysis, or leukemic organ involvement. Total bilirubin WBC \\\u003C 25 x 109\u002FL prior to treatment initiation- subjects with WBC ≥ 25 x 109\u002FL may still be eligible after receiving cytoreduction measures such as hydroxyurea and\u002For leukapheresis if WBC becomes \\\u003C 25 x 109\u002FL prior to treatment initiation. Cytoreduction with hydroxyurea and\u002For leukapheresis is allowed prior to treatment. Hydroxyurea must be discontinued ≥ 12 hours prior to treatment initiation.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration:\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) unless considered to be due to Gilbert's Syndrome, hemolysis, or leukemic organ involvement. Total bilirubin must be \\\u003C 3 x upper limit normal in subjects with Gilbert's Syndrome, hemolysis, or leukemic organ involvement.\n* Aspartate aminotransferase (AST): ≤ 3 x ULN (≤ 5 x ULN if considered to be due to myelofibrosis or leukemic organ involvement).\n* Alanine aminotransferase (ALT): ≤ 3 x ULN (≤ 5 x ULN if considered to be due to myelofibrosis or leukemic organ involvement).\n* Creatinine clearance: ≥ 30 mL\u002Fmin by Cockcroft-gault formula or measured by 24-hour urine collection.\n* Participants of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry. 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\nExclusion Criteria:\n\n* Diagnosis of de novo AML, acute promyelocytic leukemia, or accelerated or blast phase MPN without a documented prior diagnosis of ET, PV, or PMF.\n* Known CNS leukemia involvement. NOTE: Subjects with clinical suspicion or signs of neurologic deficit should undergo a screening lumbar puncture prior to enrollment to confirm lack of CNS leukemia.\n* Previous treatment with BCL-2\u002FBCL-X inhibitors (including venetoclax and navitoclax).\n* Prior allogeneic stem cell transplantation for blast phase disease. Prior allogeneic stem cell transplantation for chronic and accelerated phase MPN is allowed. Subjects must not have received transplant within 60 days. Cannot be receiving immunosuppression therapy, with the exception of prednisone ≤10mg\u002Fd (or equivalent), for the treatment or prophylaxis of GVHD. If the subject has been on immunosuppressant treatment or prophylaxis for GVHD, the treatment must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ≥ 2 GVHD.\n* Treatment with moderate or strong CYP3A4 inhibitors or strong CYP3A4 inducers within five half-lives or 14 days, whichever is shorter, prior to the initiation of study treatment.\n\nTreatment with chemotherapy, wide-field radiation, or biologic therapy, with the exception of hydroxyurea as above, and all trans-retinoic acid given initially for presumed APML, within 14 days of study entry. Prior JAK inhibitor (other than pacritinib) must be held for five half-lives prior to study entry. Administration of steroids to prevent withdrawal symptoms is allowed.\n\n* Treatment with investigational drug within five half-lives or 14 days, whichever is shorter, prior to study entry.\n* Baseline prolonged QTc of \\> 480 msec. QTc measured by Fridericia's formula (QTc=QT\u002F\\[RR1\u002F3\\]) based on the mean of triplicate reads. Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria.\n* Grade ≥2 bleeding event within the previous 3 months. Treatment with anticoagulation or antiplatelet agents (except for aspirin at dosages ≤100 mg per day or prophylactic doses of enoxaparin or heparin) within five half-lives or 7 days, whichever is shorter.\n* Any GI or metabolic condition that could interfere with absorption of oral medication.\n* Known severe (Child-Turcotte-Pugh class C) hepatic cirrhosis. Testing not required.\n* Pre-existing uncontrolled pathology such as heart failure (congestive\u002Fischemic, NYHA classes III and IV), clinically significant abnormalities on a 12-lead electrocardiogram, significant pulmonary disease, severe\u002Funstable arrhythmias\u002Fangina pectoris\u002Fhypertension, acute or chronic pancreatitis, etc. Acute myocardial infarction or stroke within 6 months of study entry.\n* Known active HIV, Hepatitis B, or Hepatitis C infection; testing not required.\n* Active uncontrolled or severe systemic infection. Enrollment is possible after control of infection, at discretion of the treating physician.\n* History of another active malignancy in the previous 2 years, with the exception of:\n\nadequately treated in situ carcinoma of the cervix, breast, prostate; basal cell carcinoma pf the skin or localized squamous cell carcinoma of the skin.\n\n* Pregnant or nursing female participants",{"count":50,"type":21},20,"INTERVENTIONAL",[53],"PHASE1","This phase I trial studies the side effects and best dose of pacritinib when given together with venetoclax and azacitidine in treating patients with accelerated and blast phase myeloproliferative neoplasms (MPN-AP\u002FBP). Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for 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. Giving pacritinib together with venetoclax and azacitidine may be safe, tolerable, and\u002For effective in treating patients with MPN-AP\u002FBP",[25],"NOT_YET_RECRUITING","2026-06-30",{"date":59,"type":34},"2026-07-01",{"date":61,"type":21},"2026-08-01",{"date":63,"type":21},"2029-08-01",{"name":65,"class":41},"Roswell Park Cancer Institute",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"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).","75 Years",{"count":76,"type":21},46,[53],"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.",[80,81,82,83,84,85,86,87,88,89,25,90],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Lymphocytic Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Myelofibrosis","Non-Hodgkin Lymphoma",{"date":92,"type":34},"2026-07-02",{"date":57,"type":34},{"date":95,"type":21},"2028-05-30",{"name":97,"class":41},"City of Hope Medical Center",3,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":66},"100645293","caris-chromoseq-data-collection-100645293","NCT07680868","Caris Chromoseq Data Collection","An Observational Study to Describe the Performance of Caris Chromoseq as Compared to Conventional Cytogenetics, FISH, and NGS Testing Among Patients Receiving the Caris Chromoseq Assay for Hematologic Malignancies","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study and has signed consent form\n2. Subject must be 18 or older\n3. Subject be diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN)\n4. Physician must order or plan to order Caris Chromoseq for their patient\n5. Physicians must order or have ordered conventional cytogenetics, FISH, and NGS testing for AML, MDS, or MPN within the same timeframe of Caris Chromoseq without intervening line of therapy.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patient for whom Caris Chromoseq is not being ordered\n2. Patient is pregnant or lactating\n3. Patient is not able or willing to provide consent to data collection for this protocol",{"count":107,"type":21},300,"The study will collect clinical data on patients who receive the Caris Chromoseq assay for an underlying hematologic malignancy. The assay provides risk stratification for patients with acute myeloid leukemia (AML) myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN). The hypothesis of the study is that Caris Chromoseq compares favorably to conventional cytogenetics, FISH, and NGS analysis in terms of risk stratification capabilities, ease of use, and turnaround time.",[110,111,112,25],"Acute Myeloid Leukemia (AML)","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Myelodysplatic Syndromes",[114,115,116,117,118],"Chromoseq","Caris","AML","MDS","MPN","2026-06-26",{"date":92,"type":34},{"date":122,"type":21},"2026-07",{"date":124,"type":21},"2029-07",{"name":126,"class":127},"Caris Science, Inc.","INDUSTRY",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":51,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":66},"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":20,"type":21},[138],"PHASE2","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.",[81,82,141,142,88,25],"Chronic Myelomonocytic Leukemia","Graft Versus Host Disease","2026-06-25",{"date":145,"type":34},"2026-06-29",{"date":147,"type":34},"2025-04-18",{"date":149,"type":21},"2028-10-15",{"name":97,"class":41},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":51,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":174,"locationsCount":66},"100636995","phase-2-a-pragmatic-clinical-trial-to-prevent-relapse-for-myeloid-malignancies-with-measurable-disease-prior-to-allogeneic-transplant-100636995","NCT07572929","A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant","PREeMPT","Inclusion Criteria:\n\n* Age ≥18 years at time of transplant.\n* Must have a diagnosis of a myeloid malignancy, myelodysplastic syndrome, myeloproliferative neoplasm (including primary or secondary myelofibrosis), or acute myeloid leukemia or biphenotypic acute leukemia.\n* Pre-transplant disease assessment must include at least one:\n* Immunophenotypic assessment by flow for aberrant blasts\n* NGS to identify persistence of malignant clones using a standard clinically available assay\n* PCR based measurement of prior identified mutations (if applicable)\n* Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nNone",{"count":159,"type":21},450,[138],"This is a prospective, open-label investigation to determine whether measurable residual disease (MRD) guided assignment of maintenance therapy is effective in patients with myeloid malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Pre-HCT, patients will undergo usual disease assessments which should include immunophenotypic and\u002For molecular testing. Based on the results of these tests, patients may or may not be recommended to receive maintenance therapy post-transplant, depending on the presence or absence of a residual malignant clone.",[163,164,25,82],"Myeloid Disorders","Myelodysplastic Syndromes",[166,167],"Allogeneic hematopoietic cell transplantation","Measurable residual disease","2026-06-19",{"date":170,"type":34},"2026-06-23",{"date":61,"type":21},{"date":173,"type":21},"2034-02-01",{"name":175,"class":41},"Medical College of Wisconsin",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":51,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":42},"100526733","phase-1-preemptive-ciml-nk-cell-therapy-after-hematopoietic-stem-cell-transplantation-100526733","NCT06138587","Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation","Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I\u002FIb Clinical Trial","Inclusion Criteria for Trial Enrollment:\n\n* Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS\u002FMPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant. Patients at high risk for post-transplant relapse include:\n\n  * De novo AML diagnosed at or after age 60, except CBF AML\n  * De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow)\n  * Secondary AML\n  * AML with 5 - \\> 10% blasts at the time of transplant who are judged by their treating clinician and study PI to have no benefit from additional pre-transplant chemotherapy\n  * Any AML transplanted in CR2 or greater\n  * TP53-mutated MDS or AML\n  * Therapy-related MDS or AML\n  * MDS with monosomy 7\n  * MDS with \\>= 5% blasts at the time of transplant\n  * MDS\u002FMPN or CMML\n* Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT):\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Serum creatinine \\\u003C\u002F= 2.0mg\u002FdL\n  * O2 saturation: ≥90% on room air\n  * LVEF \\>40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO (per FACT standards should be performed within 6 weeks of stem cell infusion), then there is no need to repeat it. Otherwise, an ECHO will need to be repeated.\n* Adult patients (age ≥ 18) eligible for and planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis. All eligibility criteria and workups for undergoing SOC allogeneic SCT for the recipient and donor will be based on institutional standards and SOPs.\n* For patients with AML, the disease must meet criteria for CR\u002FCri according to 2017 ELN guidelines, or have 5-10% blasts at the time of the transplant and in the judgement of their primary BMT clinician and study PI to have no benefit from additional pre-transplant chemotherapy. For patients with MDS or MDS\u002FMPN, the blast percentage on the bone marrow aspirate and biopsy must be less than 10%.\n* The same related donor is available to provide a non-mobilized apheresis product after the stem-cell donation.\n* ECOG performance status \\\u003C= 2 (Karnofsky \\>= 60%, see Appendix C).\n* Negative pregnancy test for women of childbearing age\n* The effects of CIML NK cells combined with IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after IL-2 dose administration.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria Trial Enrollment:\n\n* Adult participants who are eligible for and who would be expected to have a greater benefit from myeloablative conditioning in their SOC allo HSCT as judged by their treating physician\n* Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.\n* Extramedullary leukemia involving sanctuary sites not readily accessible to immune surveillance, such as CNS or testis. Other sites of extramedullary relapse (e.g., leukemia cutis, granulocytic sarcoma) are acceptable.\n* The planned use of sirolimus for GVHD prophylaxis would result in exclusion of the patient from the study. Consideration of the addition of sirolimus to the GVHD prophylaxis regimen within the first 100 days after transplant must be reviewed with the study PI.\n* Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion.\n* Prior history of solid organ (allograft) transplantation\n* Prior history of allergic reactions to cellular products\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive patients are excluded due to the potential for interaction between antiretroviral therapy as well as the risk for lethal infection in the context of marrow-suppressive therapy.\n* Patients with active and uncontrolled Hepatitis B or C are ineligible due to the high risk of treatment-related hepatotoxicity after cellular therapy.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study. 3. Diagnosed with MGUS or smoldering myeloma, and\u002For treated for multiple myeloma or plasmacytoma as long as attainment of complete remission by IMWG criteria following therapy.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion as defined below:\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria to Receive CIML NK Infusion:\n\n* Systemic steroid therapy (oral or IV) on the day of NK cell infusion\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\n* Participants who have had other investigational agents within 4 weeks prior to CIML NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior. Therapy with BCR-ABL inhibitors must be stopped at least 2 weeks before CIML NK cell infusion and may not be resumed during the DLT period. The use of tocilizumab for cytokine release syndrome after stem cell infusion does not exclude patients, but the use of steroids for the treatment of CRS excludes patients if they are still on steroids by the day of planned NK cell infusion.\n* Systemic steroid use of \\>10mg\u002Fday of prednisone equivalent is an exclusion criteria unless there is a plan for dose to be tapered below this limit within 4 weeks prior to NK cell infusion.\n\nPatients must be off systemic steroid therapy on the day of planned NK cell infusion.\n\n-The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay who do not receive a desensitization protocol prior to and during stem cell transplant, or else who do receive a desensitization protocol and have detectable DSAs +1 day after stem cell infusion.\n\nIf inclusion\u002Fexclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 48 hours to enable inclusion criteria to be met.\n\nHowever, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder are in agreement with proceeding.",{"count":184,"type":21},15,[53],"The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.\n\nNames of the study therapies involved in this study are:\n\n* CIML NK cells intravenous infusion (cellular therapy)\n* Subcutaneous Interleukin-2 (recombinant, human glycoprotein)",[82,188,189,164,25,190],"Leukemia","Leukemia, Myeloid","Myeloproliferative Disorders",[82,188,189,88,192],"MDS and Myeloproliferative Neoplasm Overlap Syndrome","2026-06-15",{"date":195,"type":34},"2026-06-17",{"date":197,"type":34},"2024-01-24",{"date":199,"type":21},"2027-11-30",{"name":201,"class":41},"Dana-Farber Cancer Institute",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":208,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":51,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":42},"100364402","phase-1-a-phase-1-trial-of-ciml-nk-cell-infusion-for-myeloid-disease-relapse-after-hematopoietic-cell-transplantation-100364402","NCT04024761","A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation","1. Inclusion Criteria:\n\n   1.1 Relapse or post-transplant persistence of AML, MDS (including JMML) or MPN (CMML, myelofibrosis or MDS\u002FMPN). Disease relapse or persistence will be defined as any measurable disease by morphology, flow-cytometry, validated tests for minimal residual disease or disease-defining mutations in the bone marrow, or non-immune privileged extramedullary sites.\n\n   1.2 Persistence of disease within 4 weeks before planned NK cell infusion and at least 2 weeks after completion of immune suppression taper as long as it is \\> 2 months after stem cell transplantation for both adult and pediatric patients. If 2 weeks after completion of the immune suppression taper is still within 2 months of the most recent stem cell transplant, then chemotherapy with Fludarabine\u002FCyclophosphamide would need to start no earlier than at least 2 months after the transplant. For adults, disease persistence after a second transplant is allowed as long as the most recent transplant was a haploidentical or HLA matched stem cell transplant. In the pediatric cohort, disease persistence or recurrence after a second transplant is allowed as long as the most recent transplant was a haploidentical or matched related donor SCT.\n\n   1.3 Available original donor (same donor as used for the most recent haploidentical or HLA matched stem cell transplant for adults, or for the most recent matched related donor or related haploidentical donor for pediatrics) that is willing and eligible for non-mobilized collection.\n\n   1.4 Age ≥12 years.\n\n   1.5 ECOG performance status ≤2. For For patients in the pediatric cohort, this corresponds to a Lansky (patients \\\u003C16 years) or Karnofsky (≥16years) performance status of ≥50.\n\n   1.6 T cell chimerism ≥20% donor-derived within the 4 weeks prior to cell infusion.\n\n   1.7 Patient with ≤80% bone marrow involvement within 4 weeks prior to cell infusion. Medications like hydroxyurea, decitabine or cytarabine are allowed to control rising blasts between study enrollment and cell infusion.\n\n   1.8 No systemic corticosteroid therapy for GVHD (≤ 5mg of prednisone or equivalent dose of systemic steroids for non-GVHD, non-autoimmune indications are allowed) for at least 4 weeks prior to cell infusion. Patients on systemic GVHD prophylaxis medications such as tacrolimus or sirolimus need to be off these medications for at least 4 weeks prior to cell infusion.\n\n   1.9 No other systemic medications\u002Ftreatments (e.g. ECP) for GVHD for at least 4 weeks prior to cell infusion.\n\n   1.10 Ability of the patient or legal guardian to understand and the willingness to sign a written informed consent document.\n\n   1.11 Adequate organ function within 2 weeks of NK cell infusion as defined below:\n   * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C3 x ULN)\n   * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n   * Serum creatinine ≤2.0mg\u002FdL\n   * O2 saturation: ≥90% on room air\n   * LVEF \\>40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO, then there is no need to repeat it. Otherwise, an ECHO will need to be repeated within 2 weeks of NK cell infusion.\n\n   1.12 Negative pregnancy test for women of childbearing potential only.\n\n   1.13 The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after the last IL-2 dose administration.\n2. Exclusion Criteria:\n\n2.1 Extramedullary relapse involving immuno-privileged sites (e.g. CNS, testes, eyes). Other sites of extramedullary relapse (e.g. leukemia cutis, granulocytic sarcoma) are acceptable.\n\n2.2 Participants who have had investigational agents within 4 weeks prior to cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior or standard chemotherapy administered more than 14 days ago. Use of hydroxyurea, hypomethylating agents, low-dose cytarabine or venetoclax to control counts within 4 weeks prior to cell infusion is permitted with study PI approval but would need to be stopped 1 day prior to administration of Fludarabine and Cyclophosphamide preceding the NK cell infusion (provided that there are no ongoing AEs attributed to these agents that would preclude start of lymphodepletion in the view of the investigator). Patients on standard of care FLT-3, IDH1, and IDH2 inhibitors can stay on this treatment. Therapy with BCR-ABL inhibitors or bcl-2 inhibitors must be stopped 2 weeks before NK cell infusion and may be resumed after the end of the DLT period.\n\n2.3 Prior history of Donor Lymphocyte Infusion (DLI) within 8 weeks of CIML NK infusion. DLI that was given before this time period and that did not result in any GVHD requiring systemic treatment is not an exclusion criterion.\n\n2.4 Prior history of severe (grade 3 or 4) acute GVHD, or ongoing active GVHD requiring systemic treatment.\n\n2.5 Solid organ transplant recipient. Prior allogeneic HLA matched or mismatched stem cell transplant is allowed in the pediatric cohort. Prior HLA matched related donor or HLA matched unrelated donor stem cell transplant is allowed in the adult cohort.\n\n2.6 History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.\n\n2.7 Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study.\n\n2.8 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n2.9 Patients who develop a critical illness prior to NK cell infusion that would contraindicate the administration of Fludarabine and Cyclophosphamide conditioning. Patients who recover from such illness may still be eligible, but this must be reviewed with the study PI. A repeat bone marrow examination may be required depending on the timing of recovery. Patients who become critically ill on the planned day of NK cell infusion are excluded if the NK cell infusion cannot be given within 48 hours of the planned day 0.\n\n2.10 Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n\n2.11 HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n\n2.12 Individuals with active uncontrolled hepatitis B or C, HIV, or HTLV-1 are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after HSCT.\n\n2.13 Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.","12 Years",{"count":210,"type":21},50,[53],"This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.",[82,164,25,214],"Juvenile Myelomonocytic Leukemia",[188],{"date":195,"type":34},{"date":218,"type":34},"2019-08-31",{"date":220,"type":21},"2026-12-01",{"name":201,"class":41},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":51,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":66},"100400356","phase-2-cpx-351-and-ivosidenib-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100400356","NCT04493164","CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)\n* Treatment naive or relapsed\u002Frefractory AML who are eligible for intensive chemotherapy. Patients with high-risk MDS or MPN (defined as International Prognostic Scoring System Revised \\[IPSS-R\\] score ≥ 4 or dynamic \\[D\\]-IPSS ≥ 3) may also be eligible after discussion with the PI\n* Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 x ULN unless deemed to be related to underlying leukemia\n* Adequate renal function including creatinine clearance ≥ 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n* Willing and able to provide informed consent\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Patients who have previously received CPX-351.\n* Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea, and\u002For cytarabine (1 or 2 doses; up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy.\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction \\\u003C 45%.\n* Patients with prior anthracycline exposure of \\> 360 mg\u002Fm2 daunorubicin (or equivalent), or \\> 210 mg\u002Fm2 daunorubicin (or equivalent) in patients with prior mediastinal radiation.\n* QTc interval using Fridericia's formula (QTcF) \\> 470 msec. A prolonged QTc interval in the setting of right bundle branch block is permitted after discussion with the PI.\n* Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).\n* Subjects with a known medical history of progressive multifocal leukoencephalopathy (PML).\n* Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing\n* Patients with a diagnosis of acute promyelocytic leukemia (APL).\n* Unresolved toxicities \\> grade 1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery.",{"count":230,"type":21},30,[138],"This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.",[234,88,25,235,236],"Acute Myeloid Leukemia With Gene Mutations","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","2026-06-10",{"date":239,"type":34},"2026-06-12",{"date":241,"type":34},"2020-12-30",{"date":243,"type":21},"2028-06-01",{"name":245,"class":41},"M.D. Anderson Cancer Center",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100642358","replacing-bone-marrow-diagnostics-with-peripheral-blood-analysis-in-mpn-patients-100642358","NCT07648433","Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in MPN Patients","Development of a Peripheral Blood Assay to Replace Bone Marrow Biopsy in Myeloproliferative Neoplasms- a Multi-center Observational Study","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Confirmed MPN diagnosis, based on the WHO criteria (Barbui 2018), which includes:\n\n   Polycythemia Vera (PV) Criteria:\n   * Elevated hemoglobin (\\>16.5 g\u002FdL for men, \\>16.0 g\u002FdL for women), hematocrit (\\>49% for men, \\>48% for women), or increased red cell mass\n   * Bone marrow biopsy showing hypercellularity with trilineage growth (panmyelosis)\n   * Presence of JAK2 mutation (V617F or exon 12)\n\n   Essential Thrombocythemia (ET) Criteria:\n   * Platelet count ≥450 ×10⁹\u002FL\n   * Bone marrow biopsy showing proliferation mainly of the megakaryocyte lineage\n   * Not meeting WHO criteria (Alaggio et al., 2022) for other myeloid neoplasms (such as CML, PV, PMF, MDS).\n   * Presence of JAK2, CALR, or MPL mutation Primary Myelofibrosis (PMF) Criteria\n   * Megakaryocytic proliferation and atypia, with or without reticulin fibrosis, and increased marrow cellularity (for prefibrotic\u002Fearly PMF) or significant reticulin\u002Fcollagen fibrosis (for overt PMF)\n   * Not meeting criteria for other myeloid neoplasms\n   * Presence of JAK2, CALR, or MPL mutation, or in their absence, another clonal marker\n3. Patients who are referred for a bone marrow biopsy due to a suspected diagnosis of MPN\n\nExclusion Criteria:\n\n1. Patients diagnosed with MPN receiving therapy\n2. Patients who have undergone a bone marrow transplant",{"count":254,"type":21},500,"This observational, multi-center study aims to collect data to develop a novel, minimally invasive diagnostic tool for myeloproliferative neoplasms (MPN) based on peripheral blood (PB) profiling of circulating hematopoietic stem and progenitor cells (cHSPCs) using single-cell RNA sequencing (scRNA-seq). Current diagnostic practice relies on bone marrow (BM) biopsy, procedures that is invasive, technically demanding, and may be inconclusive in early or prefibrotic disease stages.\n\nOur prior work established a reference atlas of healthy cHSPC subtypes and a computational pipeline capable of identifying disease-specific transcriptional changes by quantifying deviations from this reference. This study will assess whether PB-based genomic profiling can accurately distinguish MPN from non-clonal cytoses, including secondary erythrocytosis or thrombocytosis.\n\nPatients referred for bone marrow biopsy due to suspected myeloproliferative neoplasm (MPN) will undergo PB collection for genomic profiling. The study's primary objective is to develop a PB-based test by comparing the developed test diagnoses to the conventional BM-based diagnostics. Secondary objectives include evaluating its potential for MPN subtype classification, risk stratification, as well as assessing its ability to reduce the need for BM biopsies.",[25],"2026-06-09",{"date":193,"type":34},{"date":260,"type":21},"2026-06",{"date":262,"type":21},"2032-06",{"name":264,"class":41},"Weizmann Institute of Science",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":117,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":51,"phases":273,"briefSummary":274,"conditions":275,"keywords":279,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100622725","phase-1-pacritinib-with-aza-for-upfront-myelodysplastic-syndrome-100622725","NCT07387354","Pacritinib With Aza for Upfront Myelodysplastic Syndrome","A Phase 1\u002F2 Study of Pacritinib in Combination With Azacitidine for the Treatment of IPSS-M Moderate Low to Very High Risk Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria to be eligible to participate in the study:\n\n  1. Patients must have histologic evidence of intermediate to high-risk myelodysplastic syndrome defined as having an IPSS-M score of moderate low, moderate high, high or very high risk. This will be assessed based on evaluations performed prior to screening for trial. Of note, the most recent evaluation pre-trial may be used which does not have to necessarily be at diagnosis.\n  2. Subjects must have recovered from the toxic effects of any prior chemotherapy to ≤ Grade 1 (except alopecia).\n  3. Required screening visit laboratory values: CrCL ≥45; total bilirubin \\\u003C2xULN except for patients with known Gilbert's disease; SGPT (ALT) ≤2xULN, PTT ≤1.5xULN.\n  4. Negative pregnancy test for women with child-bearing potential at screening visit.\n  5. Initial screening baseline QTc ≤480ms.\n  6. Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.\n  7. Patients must have an absolute neutrophil count of ≥750 to enroll in study, this must be achieved without the addition of growth factor medication.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Any prior exposure to a hypomethylating agent (azacitidine or decitabine)\n  2. Any prior exposure to JAK2 inhibitor therapy (ie ruxolitinib or prior pacritinib therapy)\n  3. Any exposure within the past seven days of initiation of study treatment to a strong CYP3A inhibitor\u002Finducer.\n  4. Subjects must not be receiving any chemotherapy agents (except hydroxyurea) within the past thirty days.\n  5. Subjects must not be receiving growth factors (erythropoietin mimetics, granulocyte stimulating factor mimetics, thrombopoietin mimetics) for two weeks prior to enrollment bone marrow. Subjects may not receive growth factors for the duration of this study.\n  6. Subjects with a \"currently active\" second malignancy, other than curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA \\\u003C0.5 ng\u002FmL), or other adequately treated carcinoma-in-situ are eligible. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 1 year.\n  7. Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure (NYHA class 2), myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.\n  8. Bleeding event grade \\>=2 (CTCAE 5.0) within prior three months unless provoked (e.g., by surgery or trauma)\n  9. Use of anticoagulant or antiplatelet agents within fourteen days prior to day one with the exception of low dose aspirin (81mg daily).\n  10. Subjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligible.\n  11. Active or uncontrolled diarrhea or constipation.\n  12. Subjects must not have evidence of active disease in the CNS.\n  13. Subjects must not have received any investigational agents within fourteen days or five half-lives (whichever is longer) of study entry.\n  14. Subjects must not be pregnant or breastfeeding. Pregnancy tests must be obtained for all females of child-bearing potential. Pregnant or lactating patients are ineligible for this study due to the unknown human fetal or teratogenic toxicities of pacritinib. Males or women of childbearing potential may not participate unless they have agreed to use a highly effective contraceptive method (defined in section 10.4.4).\n  15. Subjects who have uncontrolled infection are not eligible. Patients must have any active infections under control. Fungal disease must be stable for at least two weeks before study entry.\n  16. Subjects with bacteremia must have documented negative blood cultures prior to study entry.\n  17. Subjects who are currently candidates for allogeneic transplantation, have a suitable donor, and are willing to undergo transplantation prior to study start.\n  18. Subjects who cannot hold a medication, over the counter, or supplemental product that in the investigator's opinion may put the patient at increased harm.",{"count":7,"type":21},[53,138],"This study will be conducted as a phase 1\u002F2 study of safety and preliminary efficacy of pacritinib in combination with azacitidine for IPSS-M moderate low to very high risk MDS. Phase one will be a 3 + 3 design to assess the dose for the phase two portion. The phase two portion will employ a simon min-max two-stage design whereby fifteen patients will be enrolled in the first stage then ten more if at least two patients in stage one have a response. The dosing of pacritinib for the phase two study will be based on the phase one findings. Standard dosing of azacitidine will be used. A correlative study will be conducted in conjunction with the trial where the investigators will measure whole blood collected pre-treatment and at four days post-treatment to measure intracellular flow and phosflow to detect JAK\u002FSTAT, NF-κβ, and AKT\u002FmTOR signaling in patient samples and how treatment affects these pathways.",[164,117,276,277,278,25],"Myelodysplastic Syndrome, Unclassifiable","Hematologic Diseases","Bone Marrow Disease",[280,281,282,283,284,285,88],"Pacritinib","Azacitidine","IPSS-M","JAK\u002FSTAT","JAK\u002FIRAK1","NF-κβ","2026-06-08",{"date":237,"type":34},{"date":122,"type":21},{"date":290,"type":21},"2027-01",{"name":292,"class":41},"Thomas Jefferson University",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":51,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":66},"100643551","phase-2-automated-total-marrow-and-lymphoid-irradiation-for-allogeneic-hematopoietic-cell-transplant-100643551","NCT07634536","Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant","Inclusion Criteria for 20 Gy Arm (Cohort A)\n\n1. Age, Performance Status, and Graft Criteria require all of the following bullet points:\n\n   * Age 18 to 60 years (inclusive)\n   * HCT Co-Morbidity score (HCT-CI) \\\u003C 5 (http:\u002F\u002Fwww.qxmd.com\u002Fcalculate-online\u002Fhematology\u002Fhct-ci)(31)\n   * Adequate performance status is defined as Karnofsky score ≥ 70%\n   * Patients must be receiving an allogeneic peripheral blood stem cell graft\n   * Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8\u002F8 matched sibling donor, 8\u002F8 matched unrelated donor, haploidentical related donor, or 7\u002F8 mismatched unrelated donor.\n2. Eligible Diseases (Any one of the following)\n\n   Acute Myeloid Leukemia (AML) Must have at least one of the following characteristics:\n   * Blasts \\>5% in the peripheral blood and\u002For bone marrow after \\>2 prior lines of AML directed therapy, present during the trial screening window\n   * Adverse plus risk by AlloHCT Refined ELN Criteria: defined as having complex cytogenetics, TP53 mutation, or MECOM rearrangement confirmed at any time point.(32)\n\n   Myelodysplastic syndrome Must have at least one of the following characteristics at the time of conditioning:\n   * Blasts \\>10% in the peripheral blood and\u002For bone marrow after \\>1 prior line of therapy.\n   * TP53 mutation confirmed at any time point\n\n   Myeloproliferative neoplasms (MPN) or MDS\u002FMPN overlap. Must have at least one of the following characteristics:\n   * Blasts \\>10% in the peripheral blood and\u002For bone marrow during the trial screening window\n   * TP53 mutation confirmed at any time point\n3. Adequate organ function is defined as all of the following:\n\n   Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \\> 50% predicted, and absence of O2 requirements. Liver: Transaminases \\\u003C 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation).\n\n   Renal: Creatinine \\\u003C 2.0 mg\u002FdL (adults) and creatinine clearance \\> 40 mL\u002Fmin.\n4. Must be FIRST allogeneic HCT\n5. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment.\n6. Voluntary written consent\n\nInclusion Criteria for 12 Gy Arm (Cohort B)\n\n1. Age, Performance Status, and Graft Criteria require all of the following bullet points:\n\n   Age 18 to 70 years (inclusive) Adequate performance status is defined as Karnofsky score ≥ 70% Patients must be receiving an allogeneic peripheral blood stem cell graft Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8\u002F8 matched sibling donor, 8\u002F8 matched unrelated donor, haploidentical related donor, or 7\u002F8 mismatched unrelated donor.\n2. Eligible Diseases (Any of the following) Acute Myeloid Leukemia (AML) Myelodysplastic syndrome Myeloproliferative neoplasm MDS\u002FMPN overlap\n3. Must have relapse after prior allo HCT\n4. Adequate organ function is defined as all of the following:\n\n   Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \\> 40% predicted, and absence of O2 requirements. Liver: Transaminases \\\u003C 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation).\n\n   Renal: Creatinine \\\u003C 2.0 mg\u002FdL (adults) and creatinine clearance \\> 40 mL\u002Fmin. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment.\n5. Voluntary written consent\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding. 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.\n2. Untreated active infection. Controlled or asymptomatic infections requiring continued antimicrobial therapy are permissible.\n3. Active HIV infection, defined as HIV infection with detectable viral load\n4. Active central nervous system malignancy\n5. GVHD requiring systemic therapy including \\> 0.25 mg\u002Fkg prednisone (or equivalent) or other systemic therapy for GVHD (e.g., tacrolimus, sirolimus, ruxolitinib, belumosodil, ibrutinib, axatilimab).\n6. Any other medical or psychological condition that is deemed serious and unsafe for clinical trial participation.\n7. Exposure to prior radiation that is deemed unsafe for clinical trial participation.","70 Years",{"count":230,"type":21},[138],"Intensive conditioning regimens used in allogeneic hematopoietic cell transplant (HCT) help to eliminate hematologic tumors and reduce the risk of relapse, but are also characterized by high toxicity. Total marrow and lymphoid irradiation (TMLI) is a specialized radiation technique that specifically targets marrow and lymphoid tissue to maximize antitumor efficacy while reducing off target toxicity. Despite these benefits, TMLI is technically challenging and time consuming. The radiation oncology team at Stanford has developed an automated TMLI platform to overcome these challenges. In this phase II trial, automation will be incorporated into a previously validated conditioning regimen of fludarabine\u002Fcyclophosphamide\u002FTMLI HCT with post-transplant cyclophosphamide (PTCy) for graft-versus-host disease (GVHD) prophylaxis to confirm the feasibility and safety of automation in patients receiving allogeneic HCT for high-risk myeloid malignancies.",[82,25,164],"2026-06-04",{"date":257,"type":34},{"date":307,"type":21},"2026-08",{"date":309,"type":21},"2028-08",{"name":311,"class":41},"Stanford University",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":319,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":322,"conditions":323,"keywords":338,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has 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, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":230,"type":21},"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[324,188,325,326,17,327,116,328,329,25,330,86,331,332,333,334,335,336,337],"Hematologic Malignancy","Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","Chronic Myelogenous Leukemia","CML","Non Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[339,340,341],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":304,"type":34},{"date":345,"type":34},"2023-11-15",{"date":347,"type":21},"2027-12-01",{"name":349,"class":41},"Children's Hospital Medical Center, Cincinnati",5,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":51,"phases":359,"briefSummary":361,"conditions":362,"keywords":367,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":66},"100494162","evaluation-of-optical-genome-mapping-in-phi-negative-myeloproliferative-neoplasia-in-the-detection-of-acquired-cytogenetic-abnormalities-100494162","NCT05714592","Evaluation of Optical Genome Mapping in Phi Negative Myeloproliferative Neoplasia in the Detection of Acquired Cytogenetic Abnormalities","MYELOCARTOCH","Inclusion Criteria:\n\n* Patient 18 years of age or older\n* Diagnosis or follow-up of polycythemia vera, essential thrombocythemia or primary or secondary myelofibrosis\n* Requires bone marrow cytogenetics at diagnosis or follow-up\n* Understanding of the French language\n* Information of the patient and collection of no objection\n* Person affiliated to a social security regime\n\nExclusion Criteria:\n\n* Patient with BCR::ABL positive myeloproliferative neoplasia.\n* Person with a medical history that may impair the ability to understand the information notice",{"count":107,"type":21},[360],"NA","Standard cytogenetics (CBA +\u002F- FISH) is of diagnostic and prognostic interest in Ph- MPN. However, its value is limited by the low frequency of detected abnormalities. The development of tools to increase the sensitivity of detection of chromosomal alterations is therefore particularly adapted to these pathologies. Optical genome mapping (OGM) is a high resolution \"long read\" technique that allows the identification of structural and copy number variations at the whole genome level. Several recent studies suggest that OGM is a future tool for cytogenetic characterization of haematological disorders. Its ability to describe structural abnormalities, including balanced ones, represents a major advantage over currently used technologies. Thus, OGM seems to be the key tool for cytogenetics of haematological malignancies in the coming years, making it possible to replace, under certain conditions, not only karyotype and FISH, but CMA and even RT-MLPA for the search for fusion transcripts, thus filling in the gaps in these techniques while maintaining their advantages.\n\nTo define the place of this technology in Ph- MPN, the investigators will perform a OGM analysis on patients with Ph-MPN for whom bone marrow exploration is scheduled. These results will be compared with those of standard cytogenetics (CBA +\u002F- FISH).",[25,363,364,365,366],"Optical Genome Mapping","Cytogenetics","Clonality","Prognostic Stratification",[25,368,364,365,369],"Optical genome mapping","Prognostic stratification","2026-05-27",{"date":372,"type":34},"2026-05-28",{"date":374,"type":34},"2023-05-17",{"date":376,"type":21},"2027-05-18",{"name":378,"class":41},"Centre Hospitalier Universitaire, Amiens",{"id":380,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":382,"keywords":383,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":388,"leadSponsor":390,"locationsCount":42},"100553015",{"count":20,"type":21},[25],[27,28,29],"2026-05-21",{"date":386,"type":34},"2026-05-22",{"date":36,"type":34},{"date":389,"type":21},"2026-09",{"name":40,"class":41},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":208,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":51,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":66},"100331014","phase-2-dexrazoxane-hydrochloride-in-preventing-heart-related-side-effects-of-chemotherapy-in-participants-with-blood-cancers-100331014","NCT03589729","Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers","Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.\n* Patients of child bearing potential should use contraception.\n* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.\n* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.\n* Patients with myeloproliferative neoplasms in blast phase will be eligible.\n* Patients with isolated extramedullary myeloid neoplasm will be eligible.\n* Patients with active CNS (central nervous system) disease are eligible.\n* Bilirubin \\\u003C 2mg\u002FdL.\n* AST (aspartate aminotransferase) and\u002For ALT (alanine aminotransferase) \\\u003C 3 x ULN (upper limit of normal) - or \\\u003C 5 x ULN if related to leukemic involvement.\n* Creatinine \\\u003C 1.5 x ULN.\n* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.\n* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).\n* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).\n* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.\n* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.\n* Decompensated heart failure (HF).\n* Clinically significant arrhythmias.\n* Severe valvular disease.\n* History of coronary artery disease (CAD).\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. 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.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per the judgment of the investigator.\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n* Men and women of childbearing potential who do not practice contraception.",{"count":399,"type":21},100,[138],"This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.",[82,403,404,405,406,25,407],"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Myeloid Sarcoma","Philadelphia Chromosome Positive","2026-05-19",{"date":386,"type":34},{"date":411,"type":34},"2018-09-19",{"date":413,"type":21},"2027-12-31",{"name":245,"class":41},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":16,"sex":17,"minAge":422,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":51,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":452},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).","6 Months","26 Years",{"count":425,"type":21},68,[138],"This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[429,430,431,81,432,433,434,435,436,437,438,439,440,441,87,442,25],"Acute Biphenotypic Leukemia","Acute Leukemia","Acute Leukemia of Ambiguous Lineage","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Mast Cell Leukemia","2026-05-11",{"date":445,"type":34},"2026-05-14",{"date":447,"type":34},"2019-08-29",{"date":449,"type":21},"2028-12-31",{"name":451,"class":41},"Fred Hutchinson Cancer Center",10,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":492},"100239986","project-every-child-for-younger-patients-with-cancer-100239986","NCT02402244","Project: Every Child for Younger Patients With Cancer","The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study","Inclusion Criteria:\n\n* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem\n* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority\n* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:\n\n  * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one \"1\" (borderline), two \"2\" (carcinoma in situ) or three \"3\" (malignant)\n  * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant\n  * All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant\n  * The following other benign\u002Fborderline conditions:\n\n    * Mesoblastic nephroma\n    * Teratomas (mature and immature types)\n    * Myeloproliferative diseases including transient myeloproliferative disease\n    * Langerhans cell histiocytosis\n    * Lymphoproliferative diseases\n    * Desmoid tumors\n    * Gonadal stromal cell tumors\n    * Neuroendocrine tumors including pheochromocytoma\n    * Melanocytic tumors, except clearly benign nevi\n    * Ganglioneuromas\n* Subjects must be =\\\u003C 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \\[NCTN\\]) therapeutic study, for which there is a higher upper age limit\n* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission\n\n  * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1","25 Years",{"count":462,"type":21},75000,"This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.",[465,466,467,468,469,470,471,472,473,474,475,476,477,478,25,479,480,481],"Adrenal Gland Pheochromocytoma","Carcinoma In Situ","Central Nervous System Neoplasm","Childhood Immature Teratoma","Childhood Kidney Neoplasm","Childhood Langerhans Cell Histiocytosis","Childhood Mature Teratoma","Congenital Mesoblastic Nephroma","Desmoid Fibromatosis","Ganglioneuroma","Lymphoproliferative Disorder","Malignant Neoplasm","Malignant Solid Neoplasm","Melanocytic Neoplasm","Neoplasm of Uncertain Malignant Potential","Neuroendocrine Neoplasm","Stromal Neoplasm","2026-05-01",{"date":484,"type":34},"2026-05-05",{"date":486,"type":34},"2015-11-03",{"date":488,"type":21},"2030-12-31",{"name":490,"class":491},"Children's Oncology Group","NETWORK",278,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":66},"100504587","mechanism-of-action-of-interferon-in-the-treatment-of-myeloproliferative-neoplasms-100504587","NCT05850273","Mechanism of Action of Interferon in the Treatment of Myeloproliferative Neoplasms","IFN&SMP","Inclusion Criteria:\n\n1. Adult male or female 18 years of age or older\n2. Diagnosis of MPN has been previously established by the referring physician and that physician will have decided to treat with pegylated IFN. Patients will be treated or untreated at the time of inclusion and may be newly diagnosed patients.\n3. These patients will be affiliated with or benefit from a social security plan\n4. For all these patients an additional 20-40 mL will be collected except for some PV patients who are treated conventionally by phlebotomy. In this case, we will collect blood bags from these patients. The volumes vary between 300 and 450 mL of blood depending on the weight and size of the patients.\n5. We will also include in this protocol any patient whose MPN, either PV, TE or MF, will have progressed to acute leukemia (AL) during treatment. These will be patients with AP of MPN (MPN can also progress to acute myeloid leukemia (AML) by acute transformation (AT) of MPN).\n6. Patient with signed informed consent\n\nExclusion Criteria:\n\n1. The non-inclusion criterion concerns the anemia that some MF patients may suffer from. Therefore, patients with anemia (Hb\\\u003C10g) or transfusion dependency (≥ 1 packed red blood cell per month) at the time of the referral monitoring visit are not included in the research.\n2. Persons under court protection, guardianship or curatorship",{"count":501,"type":21},80,"Classical BCR-ABL-negative myeloproliferative neoplasms (MPN) include: Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF). They are myeloid malignancies resulting from the transformation of a multipotent hematopoietic stem cell (HSC) caused by mutations activating the JAK2\u002FSTAT pathway. The most prevalent mutation is JAK2V617F. Type 1 and Type 2 calreticulin (CALR) and thrombopoietin receptor (MPL) mutations are also observed in ET and PMF. Additional non-MPN mutations affecting different pathways are also found, particularly in PMF, and are involved in disease initiation and\u002For in phenotypic changes and \u002For disease progression and\u002For response to therapy.\n\nThere is an obvious and urgent need for an efficient therapy for MPN. In particular, PMF remain without curative treatment, except allogeneic HSC transplantation and JAK inhibitors have limited effects on the disease outcome. Among novel therapeutic approaches, Peg-IFNα2a (IFN) is the most efficient harboring both high rates of hematological responses in JAK2V617F and CALRmut MPN patients and some molecular responses mainly in JAK2V617F patients including deep molecular response (DMR). Nevertheless, several studies, including our own, have demonstrated that the IFN molecular response in CALRmut patients is heterogeneous and overall much lower than in JAK2V617F patients. Moreover, some JAK2V617F MPN patients do not respond to IFN, and DMR is only observed in around 20% of JAK2V617F patients. Finally, long-term treatments are needed (2-5 years) to obtain a DMR, jeopardizing its success due to possible long-term toxicity.\n\nThe underlying reasons for failure, drug resistance, heterogeneous molecular response in CALRmut patients and the long delays for DMR in JAK2V617F patients remain unclear, largely because the mechanisms by which IFNα targets MPN malignant clones remain elusive.\n\nSignificant improvement of IFN efficacy cannot be achieved without basic and clinical research. Hence our two lines of research are to\n\n* Understand how IFNα specifically targets neoplastic HSCs\n* Predicting and improving patient response during IFNα therapy",[25],[505,506,507],"interferon alpha","Hematopoietic stem cell","mechanism of action","2026-04-13",{"date":510,"type":34},"2026-04-14",{"date":512,"type":34},"2023-03-16",{"date":514,"type":21},"2033-03-16",{"name":516,"class":517},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":51,"phases":526,"briefSummary":527,"conditions":528,"keywords":535,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":66},"100384169","phase-2-decitabine-with-ruxolitinib-fedratinib-or-pacritinib-for-the-treatment-of-acceleratedblast-phase-myeloproliferative-neoplasms-100384169","NCT04282187","Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated\u002FBlast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* History of MPN as defined by the 2016 World Health Organization criteria, with now pathologically confirmed \\>= 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN unclassifiable, MDS\u002FMPN overlap\n* Outside diagnostic material is acceptable as long as peripheral blood and\u002For bone marrow slides are reviewed at the study institution by pathology. Flow cytometric analysis of peripheral blood and\u002For bone marrow should be performed according to institutional practice guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky \\>= 60%\n* Serum creatinine clearance \\>= 50 ml\u002Fmin calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)\n* Total bilirubin =\\\u003C 3 unless due to Gilbert's disease or hemolysis (total bilirubin \\> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) unless thought to be due to MPN disease process (AST\u002FALT \\> 3 is allowable if thought due to MPN disease) (assessed within 14 days of study day 1)\n* For patient receiving fedratinib, thiamine level should be above the laboratory lower limit of normal (\\>= 70 nmol\u002FL in the University of Washington \\[UW\\]\u002FSeattle Cancer Care Alliance \\[SCCA\\] lab). If it is low, it may be repleted but should be rechecked and demonstrated to normalize prior to initiation of therapy\n* Patient is considered a potential transplant candidate. The attending\u002Ftreating physician will determine transplant candidacy at the time of consent\n* The use of hydroxyurea prior to study registration is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood count (WBC) \\> 100,000\u002FuL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 \u002Fdose) anytime prior to enrollment\n* Capable of providing valid informed consent\n\nExclusion Criteria:\n\n* Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN with \\>= 5% blasts in the blood or marrow. Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy is allowed\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable (e.g. if specific, effective therapy is not available\u002Ffeasible or desired \\[e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)\\])\n* Known hypersensitivity to any study drug\n* Females who are pregnant or breastfeeding\n* Treatment with any other anti-MDS\u002Fleukemia investigational agent within 2 weeks of start of study drugs\n* For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued\n* For patients planned to receive ruxolitinib AND platelets \\\u003C 50,000\u002Fmm\\^2: concurrent use of a strong CYP3A4 inhibitor that cannot be discontinued\n* For patients planned to receive pacritinib, corrected QT interval (QTc) \\> 480 msec (changing of medications\u002Fsupplementing electrolytes is allowed to determine if this helps QTc reduce to \\\u003C 480 msec)\n* For patients planned to receive pacritinib, concurrent use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, OCT1 substrates that cannot be discontinued",{"count":7,"type":21},[138],"This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib, fedratinib, and pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib, fedratinib, or pacritinib may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated\u002Fblast phase myeloproliferative neoplasms.",[82,529,88,530,25,531,532,533,534],"Essential Thrombocythemia","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myeloproliferative Neoplasm, Not Otherwise Specified","Polycythemia Vera","Primary Myelofibrosis","Secondary Myelofibrosis",[536,537],"Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-03-11",{"date":540,"type":34},"2026-03-16",{"date":542,"type":34},"2020-03-24",{"date":544,"type":21},"2026-11-11",{"name":546,"class":41},"University of Washington",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":554,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":51,"phases":558,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":98},"100360206","phase-2-graft-versus-host-disease-reduction-strategies-for-donor-blood-stem-cell-transplant-patients-with-acute-leukemia-or-myelodysplastic-syndrome-mds-100360206","NCT03970096","Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)","A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)","Inclusion Criteria:\n\n* Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:\n\n  * Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\\\u003C 5% marrow blasts by morphology).\n  * Acute myeloid leukemia (AML) in first or subsequent morphological remission (\\\u003C 5% marrow blasts by morphology).\n  * Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic myeloid leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology).\n  * Myelodysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or cytotoxic chemotherapy) within the past 3 months.\n* Patient age 1-60 years old (inclusive) at the time of informed consent\n\n  * Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens.\n  * Patients aged 1-60 years old (inclusive) are eligible for busulfan-based conditioning regimens (with or without TBI 4 Gy).\n* Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 matched) related or unrelated donor capable of donating PBSC.\n* Recipient informed consent\u002Fassent and\u002For legal guardian permission must be obtained.\n* DONOR: HLA-matched related and unrelated donors (HLA-A, B, C, DRB1 and DQB1 matched based on high-resolution typing).\n* DONOR: \\>= 18 years old.\n* DONOR: Willing to donate PBSC.\n* DONOR: Matched related donors:\n\n  * Must give informed consent using the related donor informed consent form.\n  * Must meet institutional donor eligibility criteria or be ineligible with statement that the donor is a first or second degree relative (exception 21 Code of Federal Regulations \\[CFR\\] 1271.65(b)(i)).\n* DONOR: Matched unrelated donors:\n\n  * Must consent according to the applicable National Marrow Donor Program (NMDP) donor regulatory requirements.\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii)).\n\nExclusion Criteria:\n\n* Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard cranial-spinal radiation. A patient may have a history of CNS disease. However, any CNS disease must be cleared by the end of the pre-conditioning evaluation time frame. If CNS disease is identified on cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for prevention of GVHD.\n* Patient weight:\n\n  * Patients with HLA-matched related donors will be excluded if they weigh \\>= 110 kg.\n  * Patients with HLA-matched unrelated donors will be excluded if they weigh \\>= 110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh \\>= 90 kg.\n* Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.\n* Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician; i.e. patients with active infections require infectious disease consultation and documentation by the infectious disease team that myeloablative HCT is not considered to be contraindicated. Upper respiratory tract infection is not considered to represent an uncontrolled infection in this context.\n* Patients with organ dysfunction, including:\n\n  * Renal insufficiency (creatinine \\> 1.5 mg\u002Fdl) at the time of evaluation for the protocol. Patients with a known history of creatinine \\> 1.5 mg\u002Fdl or a current serum creatinine above the normal range for age must have a current creatinine clearance of \\> 60 ml\u002Fmin\u002F1.73 m\\^2 (measured by 24-hr urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n  * Left ventricular ejection fraction \\\u003C 45%.\n  * Carbon monoxide diffusing capability (DLCO) corrected \\\u003C 60%. Patients who are unable to perform pulmonary function tests (for example, due to young age and\u002For developmental status) will be excluded if the oxygen (O2) saturation is \\\u003C 92% on room air.\n  * Liver function abnormality. Patients who have liver function test (LFT)s (specifically, total bilirubin, aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\>= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, MTX, trimethoprim-sulfamethoxazole, or another drug). If the GI physician considers that HCT on the protocol is contraindicated, that patient will be excluded from the protocol. Patients with Gilbert's syndrome require GI physician consultation but may be included on the protocol. Patients with no other known liver function abnormality or with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol.\n* Patients who have received previous myeloablative allogeneic or autologous transplantation.\n* Patients with a life expectancy \\\u003C 12 months from co-existing disease other than the leukemia or MDS.\n* Patients who are pregnant or breast-feeding.\n* Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT.\n* Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n* Patients with a known hypersensitivity to tacrolimus or MTX\n* Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI\n* DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection. Test must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits (serological and\u002For nucleic acid amplification test \\[NAT\\] and\u002For other approved testing) in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory.\n* Unrelated donors donating outside of the USA.","1 Year","60 Years",{"count":557,"type":21},120,[138],"This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[430,81,82,88,25],[562,536,537],"Lymphoid Leukemia","2026-03-10",{"date":565,"type":34},"2026-03-12",{"date":567,"type":34},"2019-11-19",{"date":569,"type":21},"2029-12-31",{"name":451,"class":41},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":51,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":590},"100321927","phase-1-ivosidenib-and-venetoclax-with-or-without-azacitidine-in-treating-patients-with-idh1-mutated-hematologic-malignancies-100321927","NCT03471260","Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies","Phase Ib\u002FII Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +\u002F- Azacitidine in IDH1-Mutated Hematologic Malignancies","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. ECOG performance status of \\\u003C 2.\n3. IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the PI.\n4. Relapsed\u002Frefractory AML, or treatment-naïve patients with AML who are not eligible for standard induction chemotherapy. Patients with high-risk MDS, MDS\u002FMPN or MPN (defined as \\> 10% bone marrow blasts, or intermediate or high risk by IPSS, R-IPSS or D-IPSS) that have failed standard therapy may also be eligible after discussion with the PI.\n5. Adequate hepatic function (direct bilirubin \\\u003C 2 x ULN, ALT and\u002For AST \\\u003C 3x ULN) unless deemed to be related to underlying leukemia.\n6. Adequate renal function including creatinine clearance \\> 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n7. Willing and able to provide informed consent\n8. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n9. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Patients with known allergy or hypersensitivity to ivosidenib or venetoclax.\n2. Patients who have previously received either ivosidenib or venetoclax.\n3. Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n4. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea and\u002For one dose of cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.\n5. Patients receiving concomitant strong CYP3A inducers (avasimibe, carbamazepine, phenytoin, rifampin, rifabutin, St. John's wort) within 3 days of start of study therapy.\n6. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n7. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Patients with a concurrent active malignancy under treatment.\n9. QTc interval using Fridericia's formula (QTcF) \\> 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI.\n10. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n11. Subject has a white blood cell count \\> 25 x 10⁹\u002FL. (Note: Hydroxyurea is permitted to meet this criterion.)\n12. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).",{"count":579,"type":21},96,[53,138],"This phase Ib\u002FII trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, 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. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.",[82,583,88,25,235,236],"Hematopoietic and Lymphoid System Neoplasm",{"date":538,"type":34},{"date":586,"type":34},"2018-03-19",{"date":588,"type":21},"2027-09-30",{"name":245,"class":41},4,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":598,"targetDuration":4,"studyType":51,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":98},"100520655","phase-2-cmv-mva-triplex-vaccination-in-hla-matched-related-stem-cell-donors-for-the-prevention-of-cmv-infection-in-patients-undergoing-hematopoietic-stem-cell-transplant-100520655","NCT06059391","CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant","Placebo-Controlled and Randomized Phase 2 Trial of CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients After Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* DONORS: Age: 18 and above\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\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 and above\n* RECIPIENTS: Karnofsky performance score ≥ 70 or ECOG ≤ 2\n* RECIPIENTS: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and Non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma are excluded\n* RECIPIENTS: CMV seropositive\n* RECIPIENTS: Planned related HCT with 8\u002F8 (A, B, C, DRB1) high resolution human leukocyte antigen (HLA) donor allele matching\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted. Patients may receive myeloablative, reduced intensity, or nonmyeloablative conditioning\n* RECIPIENTS: Total bilirubin ≤ 2 X upper limit of normal (ULN) (unless has Gilbert's disease)\n* RECIPIENTS: Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* RECIPIENTS: Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* RECIPIENTS: Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50% Note: To be performed within 45 days prior to day 1 of protocol therapy\n* RECIPIENTS: If able to perform pulmonary function tests: forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin). If unable to perform pulmonary function tests: oxygen (O2) saturation \\> 92% on room air Note: To be performed within 45 days prior to day 1 of protocol therapy\n* RECIPIENTS: Seronegative for human immunodeficiency virus (HIV) antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV)\\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\])\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 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\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 for 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\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 of 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 S (HbSS), sickle cell trait (HbAS), hemoglobin sickle C disease (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: Positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I\u002FII)\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: Prior allogeneic (allo) transplant for any condition\n* RECIPIENTS: Live attenuated vaccines\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)\n* RECIPIENTS: Allergy treatment with antigens injections\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as valganciclovir\u002Fganciclovir (GCV\u002FVAL), foscarnet (FOS), cidofovir, brincidofovir (CMX-001), maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment\n* RECIPIENTS: Other investigational product - 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\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product\n* RECIPIENTS: Diagnosis with autoimmune disease\n* RECIPIENTS: Females only: Pregnant women and women who are lactating. The risks of Triplex to pregnant women are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother. Breastfeeding should be discontinued if the mother is enrolled on this study\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":599,"type":21},216,[138],"This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.",[81,82,83,603,583,86,88,89,25,90],"Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-03-06",{"date":563,"type":34},{"date":607,"type":34},"2024-07-12",{"date":609,"type":21},"2029-01-01",{"name":97,"class":41},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":51,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":42},"100448738","phase-1-an-optimal-dose-finding-study-of-n-acetylcysteine-in-patients-with-myeloproliferative-neoplasms-100448738","NCT05123365","An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* ≥18 years of age\n* Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria\n* Has not taken interferon-alpha or a JAK inhibitor (such as ruxolitinib or fedratinib) for treatment of MPN in the past 28 days before enrollment.\n* May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen.\n* Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment.\n* Baseline MPN-TSS score of ≥ 10 at the time of enrollment.\n* Peripheral blast count \\\u003C10% during Screening.\n* Free of other active or metastatic malignancies other than localized skin cancer.\n* Amenable to blood draws and symptom assessments.\n* Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3\n* Currently pregnant or planning on being pregnant within the study period.\n* Currently breastfeeding.\n* Known uncontrolled active viral or bacterial infection.\n* Significant impairment of major organ function defined as\n\n  1. Serum creatinine clearance less than 50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin more than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.\n  3. Platelets \\\u003C 100 × 10\\^9\u002FL\n  4. Hgb \\\u003C 10 g\u002FdL\n  5. ANC \\\u003C 0.75 × 10\\^9\u002FL\n* Known history of allergic reaction to N-AC.",{"count":618,"type":21},27,[53,138],"This is a phase I\u002FII study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).",[25,118,529,532,89],[118,25,623,532,89],"Essential Thrombocytemia",{"date":563,"type":34},{"date":626,"type":34},"2022-01-03",{"date":628,"type":21},"2026-11-15",{"name":630,"class":41},"University of California, Irvine",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":51,"phases":640,"briefSummary":641,"conditions":642,"keywords":645,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":452},"100434814","interest-of-calr-allele-burden-in-diagnosis-and-follow-up-of-patients-with-calr-mutated-myeloproliferative-syndromes-calrsuivi-100434814","NCT04942080","Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)","CALRSUIVI","Inclusion Criteria:\n\n* adults (age ≥18 years),\n* affiliated to the national social security system,\n* with CALR mutated myeloproliferative neoplasm diagnosed between 2006 - 2020,\n* for which at least one sample is available at the time of diagnosis or before cytoreductive treatment,\n* who signed the consent to participate in the study,\n* included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).\n\nExclusion Criteria:\n\n* patient with another active hematological disease or cancer at the time of diagnosis,\n* person subject to legal protection scheme or incapable of giving consent.",{"count":639,"type":21},260,[360],"Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.",[25,529,643,644],"Primary Myelofibrosis, Prefibrotic Stage","Primary Myelofibrosis, Fibrotic Stage",[646,25,529,533,647],"CALR","Thrombocytosis","2026-03-05",{"date":604,"type":34},{"date":651,"type":34},"2021-10-28",{"date":653,"type":21},"2030-04-28",{"name":655,"class":517},"University Hospital, Angers"]