Decitabine Plus mBU/CY for High Risk Acute Leukemia With Minimal Residual Disease Pre-HSCT

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 (mBU/CY) 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 People's Hospital. Participants receive decitabine intravenously on days -12 and -11 before transplantation. For patients receiving HLA-mismatched transplants, the conditioning regimen includes modified BU/CY 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