[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636198":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":54,"collaborators":34,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":34,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":34,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":34,"overallStatus":83,"whyStopped":34,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR2554\u002FAZA + Overlapped TBF","EXPERIMENTAL","SHR2554 350 mg BID and azacitidine 75 mg\u002Fm² daily on days -9 to -3, overlapping with TBF conditioning: thiotepa 5 mg\u002Fkg on days -8 and -7; cytarabine 2 g\u002Fm² q12h on day -6; busulfan 0.8 mg\u002Fkg q6h on days -5, -4, -3 (total 3.2 mg\u002Fkg\u002Fday); fludarabine 30 mg\u002Fm²\u002Fday on days -6 to -2.",[13],"Combination Product: SHR2554\u002FAZA + Overlapped TBF",{"label":15,"type":16,"description":17,"interventionNames":18},"mBUCY conditioning Regimen Group","ACTIVE_COMPARATOR","semustine 250 mg\u002Fm² on day -8; cytarabine 2 g\u002Fm² q12h on day -7; busulfan 0.8 mg\u002Fkg q6h on days -6, -5, -4 (total 3.2 mg\u002Fkg\u002Fday); cyclophosphamide 1.8 g\u002Fm²\u002Fday on days -3 and -2.",[19],"Drug: mBUCY conditioning regimen",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","SHR2554\u002FAZA + Overlapped TBF conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT) : Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.",[9],[26],"Experimental Group",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","mBUCY conditioning regimen","mBUCY conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT): Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.",[15],[33],"Control Group",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"LIMIN LIU, MD","CONTACT","+86-512-6778183","Liminliu1006@163.com",[42],{"facility":5,"status":34,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":34},"Suzhou","Jiangsu","215006","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.59538,31.30408,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Limin Liu,MD","Principal Investigator","100636198","phase-2-shr2554aza--overlapped-tbf-for-high-riskrelapsed-leukemiamds-100636198",false,"NCT07562568","SHR2554\u002FAZA + Overlapped TBF for High-risk\u002FRelapsed Leukemia\u002FMDS","A Prospective, Multicenter, Open-label, Randomized Controlled Trial of SHR2554 Plus Azacitidine in Overlapped Sequential Combination With TBF Conditioning Regimen in Patients With High-risk or Relapsed\u002FRefractory Acute Leukemia and Myelodysplastic Neoplasms","Inclusion Criteria:\n\n1. Age 15-60 years, of either sex.\n2. Diagnosis of AML or ALL according to the WHO 2022 criteria, with an indication for allogeneic hematopoietic stem cell transplantation: AML with high-risk genetics at diagnosis (risk stratification per ELN 2022) or relapsed\u002Frefractory AML (meeting any of the following: refractory-failure to achieve complete remission (CR) after two cycles of induction chemotherapy; relapse-reappearance of blasts in peripheral blood or bone marrow (≥5%) after first CR, or extramedullary relapse (EMR)). High-risk B-ALL at diagnosis (risk stratification per ELN 2022) or pre-transplant MRD-positive B-ALL. Confirmed T-ALL. History of central nervous system leukemia (CNSL) or pathologically confirmed extramedullary disease (EMD) during AML or ALL. Myelodysplastic neoplasms (MDS): IPSS score intermediate-2 or high; IPSS-R score high or very high; IPSS-M score high or very high.\n3. Availability of an appropriate HLA-matched donor.\n4. ECOG performance status 0-2.\n5. Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT\u002FAST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL\u002Fmin.\n6. Ability to understand the study and voluntary signed informed consent.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL);\n2. Active central nervous system leukemia;\n3. Prior allogeneic hematopoietic stem cell transplantation;\n4. Prior treatment with any EZH2 inhibitor;\n5. Uncontrolled active infection as assessed by the investigator;\n6. Myocardial infarction or unstable angina within the previous 6 months;\n7. Known hypersensitivity to Zeprumetostat, azacitidine, or any excipient of the mBuCy regimen;\n8. Pregnant or breastfeeding women;\n9. Any other medical condition that, in the investigator's judgment, would preclude study enrollment.","ALL","15 Years","60 Years",{"count":69,"type":70},160,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-60 years with high-risk or relapsed\u002Frefractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic neoplasms (MDS), diagnosed based on bone marrow morphology, immunophenotyping, genetic testing, and treatment response assessment. The experimental group received SHR2554 combined with azacitidine as an overlapped sequential combination with the TBF conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT. Secondary endpoints included 2-year overall survival (OS), 2-year disease-free survival (DFS), transplant-related mortality (TRM), the incidence of acute and chronic graft-versus-host disease (GVHD), and safety profiles.",[76,77,78,79,80,81,82],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","MDS","Transplantation, Stem Cell","Conditioning Therapy","SHR2554","Azacytidine","NOT_YET_RECRUITING","2026-04-26",{"date":86,"type":87},"2026-05-01","ACTUAL",{"date":89,"type":70},"2026-06",{"date":91,"type":70},"2030-06",{"name":5,"class":6},1]