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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.
Shanghai Children's Medical Center
Shanghai, China
RECRUITINGLog number of In Vitro T cells depletion
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Time frame: One week
Incidence of grade II-IV acute GVHD
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
Time frame: up to 3 months
Grade I aGVHD
Incidence of grade I acute GVHD until Day 100 post-transplantation
Time frame: up to 3 months
cGVHD
Incidence and severity of chronic GVHD in 1 year and 2 years
Time frame: 2 years
NRM
Incidence of NRM at all visits throughout the study
Time frame: 1 year
Graft failure
incidence of Graft failure from Day 0 to Day 28
Time frame: 1 month
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