Phase III Trial Comparing Two Conditioning Drug Combinations in Children With Acute Myeloid Leukemia Undergoing Stem Cell Transplant

What this Trial Is About

Researchers are evaluating two different chemotherapy preparation plans, called conditioning regimens, for children with Acute Myeloid Leukemia AML who are undergoing allogeneic stem cell transplantation. The study aims to determine if a regimen with one alkylator drug plus two antimetabolite drugs results in better 2-year survival without severe graft-versus-host disease GvHD or relapse compared to a regimen with three alkylator drugs. This is a phase III, randomized, open-label study conducted at multiple centers. The trial compares two treatment groups one receiving a three alkylator combination of busulfan, cyclophosphamide, and melphalan BuCyMel, and the other receiving a combination of clofarabine, fludarabine, and busulfan CloFluBu where two alkylators are replaced by antimetabolites. Participants are randomly assigned to one of these conditioning regimens before their stem cell transplant. The study also includes an observational part for patients who are not eligible or do not consent to the randomized part, allowing researchers to register their outcomes. During the study, participants will undergo regular evaluations including survival status, incidence of GvHD, relapse rates, and various blood and immune system tests up to two years after transplantation. Researchers will monitor transplant-related complications, quality of life, and long-term effects on nutrition and hormones. The total follow-up period for measuring these outcomes is two years, with data collected on engraftment success and transplant-related mortality as well.

Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML