[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mrd-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mrd-positive":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100626873","phase-3-cd19-car-t-vs-dli-for-post-hsct-mrd-in-ph--all-a-rct-100626873",false,"NCT07441291","CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT","CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* age 3-\\\u003C80 years\n* ECOG performance status 0-2\n* post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)\n* no hematological\u002Fextramedullary relapse\n* adequate organ function\n* negative pregnancy test (for fertile females)\n\nExclusion Criteria:\n\n* active infections\n* uncontrolled graft-versus-host disease (GVHD)\n* history of central nervous system disorders\n* autoimmune diseases\n* other active malignancies","ALL","3 Years","79 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).\n\nPatients (aged 3-\\\u003C80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.\n\nThe primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity.\n\nThe study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.",[27,28,29],"B ALL","Allogenetic Hematopoietic Stem Cell Transplantation","MRD-positive",[31,32,33,34,35],"CD19 CAR-T","Donor Lymphocyte Infusion (DLI)","Ph-negative B-ALL","Minimal Residual Disease (MRD)","Hematopoietic Stem Cell Transplantation (HSCT)","RECRUITING","2026-02-24",{"date":39,"type":40},"2026-02-27","ACTUAL",{"date":42,"type":40},"2025-11-30",{"date":44,"type":21},"2028-12-30",{"name":46,"class":47},"Peking University People's Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100511555","phase-2-inotuzumab-ozogamicin-in-the-treatment-of-mrd-after-hsct-of-all-100511555","NCT05940961","Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL","A Multicenter Prospective Clinical Study of Inotuzumab Ozogamicin (INO) in the Treatment of Minimal Residual Disease Recurrent After Hematopoietic Stem Cell Transplantation of Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n1. Patients aged ≥ 15 and ≤ 65 years.\n2. Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard.\n3. CD22+ B-ALL patients with MRD recurrence after HSCT. Ph+ ALL patients were eligible if treatment with 1 or more second-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) had failed,\n4. ECOG performance status score less than 3.\n5. Expected survival time #3 months.\n6. Patients without serious heart, lung, liver, or kidney disease.\n7. Ability to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures.\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.\n3. Active infection.\n4. Active bleeding.\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.\n7. Liver function abnormalities (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value).\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.\n9. Surgery on the main organs within the past six weeks.\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.\n11. Patients who have received organ transplants (excepting bone marrow transplantation).\n12. Patients not suitable for the study according to the investigator's assessment.","15 Years","65 Years",{"count":59,"type":21},42,[61],"PHASE2","As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.\n\nMRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.",[16,29,64],"Hematopoietic Stem Cell Transplantation","2025-11-18",{"date":67,"type":40},"2025-11-21",{"date":69,"type":40},"2022-08-01",{"date":71,"type":21},"2026-08-01",{"name":73,"class":47},"Sheng-Li Xue, MD"]