Phase 2 Study Comparing Bendamustine Versus Ruxolitinib with Fludarabine and Busulfan Conditioning in Adults Undergoing Haploidentical Stem Cell Transplant for Blood Cancers

What this Trial Is About

Researchers are evaluating two conditioning treatments for patients undergoing haploidentical hematopoietic stem cell transplantation HCT for various blood cancers, including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. This Phase 2 trial aims to compare the addition of bendamustine versus ruxolitinib to the commonly used fludarabine and busulfan regimen. The main goal is to reduce events such as graft failure, relapse, and non-relapse mortality, considering disease risk and donor age as key factors. Participants receive one of two treatment plans. One group gets fludarabine and busulfan along with bendamustine given intravenously before transplantation, followed by cyclophosphamide and oral ruxolitinib after transplantation. The other group receives fludarabine and busulfan with oral ruxolitinib starting before transplantation, continuing with cyclophosphamide and ruxolitinib after transplantation. Each treatment includes specific dosing schedules over days before and after the stem cell transplant. During the study, participants are closely monitored for survival without major complications over two years. Researchers will assess graft failure rates, adverse events, infections, and graft-versus-host disease at various times up to two years. The study includes safety and toxicity checks, infection tracking, and overall survival analysis. Participants health and response to treatment are regularly evaluated through clinical assessments and laboratory tests throughout the study period.

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT