Study Comparing TCR Depleted Stem Cell Transplant to Traditional Haploidentical Transplant in Children Single-Center, Non-Randomized Clinical Trial for Haploidentical Hematopoietic Stem Cell Transplantation

What this Trial Is About

This research aims to compare two methods of haploidentical hematopoietic stem cell transplantation in children aged 8 weeks to 18 years who require this treatment but do not have a suitable donor with 910 or higher HLA match. The study evaluates the use of CliniMACS TCR cell depleted stem cells versus the conventional Beijing protocol, focusing on reducing the incidence of grade II-IV acute graft-versus-host disease aGVHD and improving quality of life. It is a single-center, prospective, non-randomized controlled clinical study conducted in China. Participants will receive either the traditional Beijing haploidentical transplant or an experimental TCR depleted haploidentical transplant using the CliniMACS system to deplete TCR cells from the donors mobilized peripheral blood stem cells. The study compares these two approaches to observe if the experimental method decreases GVHD and enhances patient outcomes. The treatments are administered during the transplantation procedure as per the assigned protocol. Throughout the study, children will be monitored for the incidence of acute GVHD and treatment-related mortality at day 100 post-transplant. Longer-term outcomes including graft-versus-host disease, treatment-related mortality, graft-versus-host disease-free survival, and overall survival will be assessed at one and two years after transplantation. Safety monitoring and quality of life assessments will be part of participant evaluations during the study, which is expected to continue until March 2028.

Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT