Randomized Study Comparing Two Radiation Conditioning Methods for Haploidentical Stem Cell Transplant in Children with Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are comparing two conditioning regimens for children aged 1 to 17 years with acute lymphoblastic leukemia ALL who are undergoing haploidentical allogeneic hematopoietic stem cell transplantation haplo-HSCT. The study evaluates Total Body Irradiation TBI versus Total Marrow, Central Nervous System and Lymphoid Irradiation TMLI. Both regimens are supported by medical literature, but it is unclear which is better. The goal is to find the best regimen to reduce leukemia relapse and improve survival while minimizing side effects. Participants receive either the TMLI regimen or the TBI regimen, each combined with cyclophosphamide. Both radiation treatments deliver a total dose of 12 Gy over three days before transplantation, with 2 Gy given twice daily for six fractions. Cyclophosphamide is administered at 120 mgkg over two days following radiation. The study is open-label, randomized, and multicenter, aiming to provide evidence on which conditioning method is optimal for pediatric ALL patients undergoing haplo-HSCT. During the study, participants are monitored for relapse-free survival, overall survival, and acute graft-versus-host disease over two years and 100 days respectively. Researchers also assess transplant-related mortality, relapse rates, and conditioning-related side effects. The follow-up includes clinical evaluations and safety monitoring to understand treatment impact and patient outcomes. The total participation duration includes the conditioning period, transplantation, and extended follow-up for at least two years.

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