SHR2554/AZA + Overlapped TBF for High-risk/Relapsed Leukemia/MDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR2554/AZA + Overlapped TBF, mBUCY conditioning regimen.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, MDS, Transplantation, Stem Cell. Basic parameters: 15 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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/Refractory Acute Leukemia and Myelodysplastic Neoplasms
Overview
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/refractory 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.
Interventions
- Combination product SHR2554/AZA + Overlapped TBF
SHR2554/AZA + 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 infus - 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.
Primary outcome measures
- Cumulative incidence of relapse（CIR） [Time frame: 2 years]
Secondary outcome measures (7)
- Time period for hematopoietic reconstruction [Time frame: 24 weeks]
- graft-versus-host disease (GvHD) [Time frame: 2 years]
- Overall survival（OS） [Time frame: 2 years]
- Disease-free survival（DFS） [Time frame: 2 years]
- transplant related mortality (TRM) [Time frame: 2 years]
- Regimen related toxicity [Time frame: 2 years]
- veno-occlusive disease (VOD) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Age 15-60 years, of either sex.
- 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/refractory 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.
- Availability of an appropriate HLA-matched donor.
- ECOG performance status 0-2.
- Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT/AST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL/min.
- Ability to understand the study and voluntary signed informed consent.
Exclusion criteria
- Acute promyelocytic leukemia (APL);
- Active central nervous system leukemia;
- Prior allogeneic hematopoietic stem cell transplantation;
- Prior treatment with any EZH2 inhibitor;
- Uncontrolled active infection as assessed by the investigator;
- Myocardial infarction or unstable angina within the previous 6 months;
- Known hypersensitivity to Zeprumetostat, azacitidine, or any excipient of the mBuCy regimen;
- Pregnant or breastfeeding women;
- Any other medical condition that, in the investigator's judgment, would preclude study enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07562568 · 20260414125804551