Study Comparing Two Conditioning Treatments, TBI and TMLI, Before Haploidentical Stem Cell Transplant in Adults with Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are comparing two conditioning treatments for adults with acute lymphoblastic leukemia ALL who are undergoing a special type of stem cell transplant called haploidentical allogeneic hematopoietic stem cell transplantation haplo-HSCT. The study aims to find out whether Total Marrow, Central Nervous System and Lymphoid Irradiation TMLI is more effective and less harmful than the commonly used Total Body Irradiation TBI. This research may help improve survival and quality of life for patients by identifying the best conditioning approach before transplantation. Participants will be randomly assigned to receive either the TMLI or TBI regimen, both combined with the drug cyclophosphamide. Both radiation treatments deliver a total dose of 12 Gy over three days, given twice daily in 2 Gy fractions. Cyclophosphamide is given over two days following the radiation. The study is open-label and conducted across multiple centers, allowing close comparison of the two regimens during the transplantation preparation phase. During the study, patients will be monitored for outcomes such as relapse-free survival, overall survival, and the occurrence of acute graft-versus-host disease over two years. Additional assessments include treatment-related mortality, relapse rates, and adverse events related to conditioning. Follow-up will involve clinical evaluations and tests to track patient health and transplant effects. The trial lasts for several years, with detailed monitoring to gather information about the best conditioning regimen for adult ALL patients receiving haplo-HSCT.

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