Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for Reducing Acute Myeloid Leukemia Relapse After Stem Cell Transplantation: A Multicenter Randomized Trial

What this Trial Is About

Researchers are evaluating whether adding Ruxolitinib and Decitabine to the standard conditioning regimen before allogeneic hematopoietic stem cell transplantation can reduce the recurrence rate in patients with high-risk acute myeloid leukemia (AML) in their first complete remission (CR1). The study aims to improve outcomes by combining targeted therapy with epigenetic regulation to enhance anti-leukemia effects while lowering toxicity, addressing the limitations of traditional regimens with high toxicity and relapse rates. The trial compares two treatment groups: one receiving a new intensified conditioning regimen that includes Decitabine (20 mg/m²/day from Day -15 to Day -10) and Ruxolitinib with a decreasing dose schedule from Day -15 to Day -2, alongside standard drugs such as Busulfan, Carmustine, Cytarabine, Cyclophosphamide or Fludarabine, and Antithymocyte Globulin; and the other group receiving the traditional Bu/Cy or BuF conditioning regimen without Ruxolitinib and Decitabine. The regimens vary slightly based on donor type and include detailed dosing schedules over approximately two weeks before transplantation. Participants will undergo allogeneic stem cell transplantation and be monitored over time to assess outcomes such as graft-versus-host disease incidence, recurrence rate, survival rates, immune cell recovery, and treatment safety at multiple time points including 30 days, 100 days, 180 days, and one year after transplantation. Researchers will also track neutrophil and platelet recovery and viral reactivation. The study involves follow-up visits and evaluations to comprehensively measure the impact of the treatment regimens over at least one year.

Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial