SHR2554/AZA + Overlapped Modified BUCY for High-risk/Relapsed Leukemia/MDS

This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-65 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 mBuCy conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 1-year event-free survival (EFS). Secondary endpoints include 2-year overall survival, 2-year cumulative incidence of relapse, transplant-related mortality, incidence of acute/chronic GVHD, and safety profiles.

NCT Number	NCT07575412
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, MDS, Transplantation, Stem Cell, Conditioning Therapy, SHR2554, Azacytidine
Enrollment	180 participants
Start Date	2026-06
Primary Completion	2029-06 (estimated)
Study Completion	2030-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-10