Randomized Study Comparing Total Body Irradiation versus Total Marrow, CNS, and Lymphoid Irradiation Conditioning for Adult Acute Lymphoblastic Leukemia Patients Undergoing Matched Sibling Donor Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating two conditioning treatments for adults with acute lymphoblastic leukemia ALL undergoing a matched sibling donor hematopoietic stem cell transplantation MSD-HSCT. The study compares Total Body Irradiation TBI and Total Marrow, Central Nervous System and Lymphoid Irradiation TMLI regimens, aiming to determine which better eliminates leukemia cells while reducing toxicity and transplant-related risks. This phase 2, open-label, randomized study seeks to improve survival and quality of life for adult ALL patients. Participants receive either the TMLI or TBI radiation regimen, each delivering a total of 12 Gy over days -7 to -5, divided into 6 fractions of 2 Gy twice daily. Both groups also receive cyclophosphamide drug treatment on days -4 and -3 at a total dose of 120 mgkg. These treatments prepare the body for stem cell transplantation from a matched sibling donor. During the study, participants are monitored for relapse-free survival, acute graft versus host disease, and overall survival over two years. Additional evaluations include transplant-related mortality and conditioning-related side effects. Regular assessments and follow-ups help measure effectiveness and safety, with the total participation lasting until study completion or longer as needed for outcome review.

A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL