Decitabine Combined with Modified Busulfan and Cyclophosphamide for Adults 18 to 55 With High-Risk Acute Leukemia and Detectable Minimal Residual Disease Before Stem Cell Transplant

What this Trial Is About

This trial focuses on patients with acute leukemia who have high-risk molecular markers and detectable minimal residual disease MRD before undergoing allogeneic hematopoietic stem cell transplantation allo-HSCT. The study aims to evaluate the effectiveness of combining decitabine with a modified busulfan and cyclophosphamide regimen mBUCY as a preparative treatment before transplantation to reduce relapse rates, which are notably high in this patient group. This is a prospective, single-arm clinical trial sponsored by Peking University Peoples Hospital. Participants receive decitabine intravenously on days -12 and -11 before transplantation. For patients receiving HLA-mismatched transplants, the conditioning regimen includes modified BUCY plus antithymocyte globulin ATG with cytarabine, busulfan, cyclophosphamide, semustine, and ATG administered on specific days leading up to transplantation. For matched sibling transplants, a similar regimen is used with hydroxycarbamide and a lower dose of cytarabine, without ATG. These detailed schedules ensure a tailored preparative treatment depending on donor matching. During the study, bone marrow samples are collected at multiple time points at the time of transplant and then at 1, 2, 3, 4.5, 6, 9, and 12 months post-transplant, followed by every six months for at least five years. These assessments monitor leukemia status and help evaluate outcomes such as relapse incidence, survival rates, and graft-versus-host disease. Participants are closely monitored to track treatment effects and safety over the long term.

Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT