Comparing Two Conditioning Regimens, TBI and TMLI, Before Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are comparing two different conditioning treatments for children with acute lymphoblastic leukemia ALL who are undergoing matched sibling donor hematopoietic stem cell transplantation MSD-HSCT. The study evaluates Total Body Irradiation TBI against Total Marrow, Central Nervous System and Lymphoid Irradiation TMLI, both combined with cyclophosphamide. The goal is to find which regimen better eliminates leukemia cells in bone marrow and lymphoid tissues while causing less damage to healthy tissues, potentially reducing relapse and transplant-related complications. Participants receive either the TMLI or TBI radiation therapy, each delivering a total dose of 12 Gy over three days with twice daily fractions. Both groups also receive cyclophosphamide at a total dose of 120 mgkg given over two days. The study is randomized and open-label, conducted across multiple centers, focusing on pediatric patients aged 1 to 17 years. The treatments are given before the stem cell transplant to prepare the body. During the study, participants will be monitored for 2 years after transplantation to assess relapse-free survival, overall survival, and acute graft-versus-host disease within the first 100 days. Additional outcomes include transplant-related mortality, relapse rate, and adverse events related to conditioning. The study tracks patient health through clinical assessments to determine which conditioning approach offers better outcomes and lower toxicity in children with ALL.

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