Study of VABu Conditioning Before Stem Cell Transplant in Older Adults with Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients aged 60 years and older who have acute myeloid leukemia AML and are undergoing allogeneic hematopoietic stem cell transplantation HSCT. This open-label, multi-center, single-arm study aims to assess important outcomes such as overall response, relapse rates, survival, graft-versus-host disease GVHD, and virus reactivation rates. Treatment-related toxicities including bone marrow suppression, infections, and organ dysfunction are also monitored. All participants will receive the VABu conditioning regimen before HSCT. This regimen includes Venetoclax taken orally daily from days -10 to -5, Azacitidine given subcutaneously daily from days -10 to -6, a single oral dose of Semustine on day -10, intravenous Cytarabine on day -1, and intravenous Busulfan every 6 hours from days -4 to -2. Dose adjustments may occur based on toxicity and individual tolerance. This treatment period precedes the stem cell transplant procedure. During the study, participants undergo evaluations including monitoring of survival rates at 1 and 2 years post-transplant, incidence of relapse, GVHD occurrence, virus reactivation, and engraftment success at day 30. Safety assessments track treatment-emergent adverse events from the treatment period through 30 days after treatment. Participants are followed closely to measure progression-free survival and other clinical outcomes over time. The total study duration spans from treatment through extended follow-up periods.

VABu Conditioning in Elderly AML HSCT