[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoid-leukemia-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoid-leukemia-all":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100582139","phase-2-a-platform-protocol-to-investigate-post-transplant-cyclophosphamide-based-graft-versus-host-disease-prophylaxis-in-patients-with-hematologic-malignancies-undergoing-mismatched-unrelated-donor-peripheral-blood-stem-cell-transplantation-100582139",false,"NCT06859424","A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","ACCELERATE","Inclusion Criteria, MAC RECIPIENTS:\n\n1. Age 18 to \\\u003C 66 years (chemotherapy-based conditioning) or \\\u003C 61 years (TBI-based conditioning) at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)\n5. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n6. Product planned for infusion is MMUD T-cell replete PBSC as allograft\n7. HCT-CI \\\u003C 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS.\n8. One of the following diagnoses:\n\n   1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 70% (Appendix I - Performance Status)\n\nInclusion Criteria, RIC\u002FNMA RECIPIENTS:\n\n1. Age ≥ 18 years at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned NMA\u002FRIC regimen (see\n5. Table 9 in Section 7.4 for allowed NMA\u002FRIC regimens)\n6. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n7. Product planned for infusion is MMUD T-cell replete PBSC allograft\n8. One of the following diagnoses:\n\n   1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \\\u003C 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.\n   4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS\u002Fmyeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n   5. Patients with lymphoma with chemosensitive disease at the time of transplantation.\n   6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.\n9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 60% (Appendix I - Performance Status)\n\nExclusion Criteria:\n\n1. Suitable HLA-matched related or 8\u002F8 high-resolution matched unrelated donor available\n2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing\n3. Subjects with a prior allogeneic transplant\n4. Subjects with an autologous transplant within the past 3 months\n5. Subjects who are breastfeeding or pregnant\n6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen\n7. Concurrent enrollment on a GVHD prevention clinical trial\n8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant\n9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.","ALL","18 Years","66 Years",{"count":20,"type":21},358,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.\n\nParticipants will:\n\n* Receive the standard or new drug combination after transplant\n* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients\n* Take surveys about physical and emotional well-being\n* Give blood and stool samples.",[27,28,29,30,31,32,33,34,35,36,37],"AML (Acute Myelogenous Leukemia)","Acute Lymphoid Leukemia (ALL)","Acute Leukemia (Category)","MDS (Myelodysplastic Syndrome)","CML (Chronic Myelogenous Leukemia)","CLL (Chronic Lymphocytic Leukemia)","Prolymphocyctic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Myeloproliferative Neoplasm (MPN)","Lymphoma","Myelofibrosis",[14,39,40],"ACCEL-001","ACCEL-002","RECRUITING","2026-03-16",{"date":44,"type":45},"2026-03-17","ACTUAL",{"date":47,"type":45},"2025-07-25",{"date":49,"type":21},"2028-06",{"name":51,"class":52},"Center for International Blood and Marrow Transplant Research","NETWORK",13,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100587570","phase-2-impact-of-low-intensity-chemotherapy-combined-with-short-course-blinatumomab-on-allo-hsct-in-adults-with-ph--b-all-100587570","NCT06930105","Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL","Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study","Inclusion Criteria:\n\nPatients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score \\\u003C3.\n\n2\\. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:\n\n* Bone marrow morphology\n* Cytochemistry\n* Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)\n* Chromosomal analysis\n* Molecular\u002Fgenetic testing. 3. Planned allo-HSCT candidates must have an eligible hematopoietic stem cell donor, including:\n* HLA-matched sibling donors\n* Unrelated donors (9\u002F10 or 10\u002F10 HLA allele-matched by high-resolution typing)\n* Haploidentical related donors. 4. No significant organ dysfunction:\n* Liver: ALT\u002FAST ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN.\n* Kidney: BUN and serum creatinine ≤1.25× ULN.\n* Cardiac:\n* No acute myocardial infarction or severe arrhythmia on ECG.\n* Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; no significant cardiomegaly, valvular disease, or congenital heart defects.\n* Pulmonary: FEV1, FVC, and DLCO ≥60% of predicted values. 5. Contraception:\n* Men, women of childbearing potential (postmenopausal women must be amenorrheic for ≥12 months), and their partners must use investigator-approved effective contraception during treatment and for ≥12 months after the last study intervention.\n\n  6\\. Informed consent: Patients and their legal guardians must provide written informed consent, demonstrate willingness to undergo allo-HSCT, and agree to comply with treatment protocols, follow-up schedules, and laboratory tests.\n\nExclusion Criteria:\n\n1. Non-de novo patients(i.e., relapsed\u002Frefractory disease).\n2. BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).\n3. Uncontrolled active infections or viral diseases:\n\n   * Active bacterial, viral, or fungal infections requiring treatment.\n   * Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.\n   * Hepatitis C: HCV antibody-positive with detectable HCV RNA.\n   * Syphilis: Positive TRUST test.\n   * HIV: HIV antibody-positive.\n4. Major organ dysfunction or comorbidities:\n\n   * Cardiovascular:\n   * Uncontrolled hypertension, hypertensive crisis, or encephalopathy.\n   * History of congestive heart failure (CHF), unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia).\n   * Arterial thrombosis within 3 months (e.g., stroke, transient ischemic attack).\n   * Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months.\n   * Coronary angioplasty, defibrillation, or other high-risk cardiovascular procedures.\n   * Pulmonary: Severe respiratory insufficiency.\n   * Gastrointestinal: Active bleeding within 3 months.\n5. Uncontrolled concurrent illnesses that may compromise safety or study integrity.\n6. Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).\n7. Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.\n8. Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).\n9. Hypersensitivity to blinatumomab or its components.\n10. Inability to provide informed consent or comply with study procedures.\n11. Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.","60 Years",{"count":63,"type":21},45,[24],"This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.\n\nTreatment Protocol\n\n1. Low-intensity chemotherapy (VIP regimen)\n\n   * V (Vincristine): 1.4 mg\u002Fm² (max 2 mg) on days 1 and 8.\n   * I (Idarubicin): 8 mg\u002Fm²\u002Fday on days 1 and 8.\n   * P (Prednisone): 60 mg\u002Fm²\u002Fday (max 100 mg\u002Fday) or equivalent dexamethasone dose on days 1-14.\n2. Sequential induction therapy:\n\n   * Blinatumomab administered for 2 weeks following the VIP regimen.\n3. Consolidation therapy for morphological complete remission (CR)\n\n   * Patients achieving CR receive two cycles of consolidation chemotherapy:\n   * Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).\n   * Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).\n4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT):\n\n   * Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.\n\nPatients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery \\[CRi\\]), MRD-negative rate (assessed by MFC\u002FNGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute\u002Fchronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free\u002Frelapse-free survival (GRFS) post-transplant.",[28],"NOT_YET_RECRUITING","2025-08-05",{"date":70,"type":45},"2025-08-06",{"date":72,"type":21},"2025-09-01",{"date":74,"type":21},"2028-05-01",{"name":76,"class":77},"Xianmin Song, MD","OTHER"]