TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

Relapsed Pediatric ALL Clinical Trial

Official title: A Multi-center Prospective Clinical Study in China Using CliniMACS TCRα/β+ and CD45RA+ T Cell Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Stem Cell Transplantation in Children With Leukemia

Status Recruiting

Clinical Trial Summary

This is a multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.

Clinical Trial Description

This clinical study will the CliniMACS TCRα/β and CD45RA Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donors to treat pediatric patients who were suffuring form relapsed or refactory leukemia.

Aming to evaluate the safety/tolerability and feasibility of haploidentical PBSC grafts depleted of TCRα/β+ and CD45RA+ cells using the CliniMACS TCRαβ/CD45RA System in pediatric patients with hematological malignancies diseases. And the incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation of this new In Vitro T cell depletion technology in China.

The investigators will monitor the incidence of grade I acute GVHD until Day 100 post-transplantation, incidence and severity of chronic GVHD after 1 year and 2 years, incidence of NRM at all visits throughout the study, and graft failure from Day 0 to Day 28 at the same time. ;

Related Conditions & MeSH terms

• Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis)
• Graft vs Host Disease
• Leukemia
• Relapsed Pediatric ALL
• Relapsed Pediatric AML

• NCT number: NCT04033627
• Study type: Interventional
• Source: Shanghai Children's Medical Center
• Contact: luo chengjuan
• Phone: +86 021 38626161
• Email: luochengjuan@scmc.com.cn
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2020
• Completion date: May 8, 2024