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Not yet taking people in ChinaPhase 2

SHR2554 and azacitidine before stem cell transplant in high-risk or relapsed leukemia and MDS

Tests SHR2554 with azacitidine before stem cell transplant in high-risk leukemia or MDS.

Plain-language title generated from the registry record
Registry title: SHR2554/AZA + Overlapped TBF for High-risk/Relapsed Leukemia/MDS

Key facts

Where
Suzhou, ChinaSee the site
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 15-60 with high-risk or relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic neoplasms who need a stem cell transplant from a compatible donor.

Age
15-60 years
Sex
All sexes can join.
Disease stage
High-risk or relapsed/refractory AML; high-risk B-ALL or B-ALL with measurable disease before transplant; T-ALL; history of central nervous system leukemia or confirmed disease outside the bone marrow; MDS with intermediate-2, high or very high risk scores.
Earlier treatment
People who had a prior allogeneic stem cell transplant or any EZH2 inhibitor cannot join. A compatible donor must be available.

Main reasons for not taking part

  • Acute promyelocytic leukemia
  • Active central nervous system leukemia
  • Prior allogeneic stem cell transplant or prior EZH2 inhibitor
  • Uncontrolled active infection
  • Pregnant or breastfeeding women

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 60 years old?

Source: NCT07562568, who can take part

Where in China

  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
The First Affiliated Hospital of Soochow University
Trial code
NCT07562568
Record updated
1 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Prior allogeneic hematopoietic stem cell transplantation; Prior treatment with any EZH2 inhibitor; Myocardial infarction or unstable angina within the previous 6 months; Uncontrolled active infection as assessed by the investigator; Known hypersensitivity to Zeprumetostat, azacitidine, or any excipient of the mBuCy regimen; Any other medical condition that, in the investigator's judgment, would preclude study enrollment; Acute promyelocytic leukemia (APL); Active central nervous system leukemia; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07562568