Stem Cell Transplant Treatment for Children and Teens With Acute Lymphoblastic Leukemia Comparing Radiation and Chemotherapy Approaches

What this Trial Is About

Researchers are studying children and adolescents with acute lymphoblastic leukemia ALL who are in complete remission and require allogeneic hematopoietic stem cell transplantation HSCT. This multinational phase III trial aims to optimize therapy by comparing chemotherapy-based conditioning regimens to total body irradiation TBI combined with chemotherapy. The study focuses on evaluating overall survival and event-free survival, considering the risks of late side effects like organ dysfunction, growth issues, hormonal problems, and secondary cancers from TBI. Participants receive one of several conditioning regimens before HSCT. These include TBI with etoposide VP16 for patients older than 4 years, or chemotherapy combinations such as fludarabine, thiotepa, treosulfan, intravenous busulfan, or busulfan with VP16 and cyclophosphamide, depending on age and donor compatibility. Some patients receive additional medications like ATG Thymoglobulin or Grafalon. The study also stratifies patients by donor type, including matched sibling, matched unrelated, and mismatched donors, to assess outcomes across these groups. During the study, participants undergo regular follow-up for up to 10 years to monitor overall survival, event-free survival, relapse, toxicity, and transplant-related mortality. Data are collected annually starting 18 months after the first patient enrollment. The trial includes assessments of acute and late side effects, with ongoing observation to understand the long-term impact of different conditioning regimens in pediatric ALL patients undergoing HSCT.

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia