This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.
Age 8 weeks to 18 years
Children who meet the indicators haploidentical hematopoietic cell transplantation
No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness
Informed consent must be signed (by the patient or legal representative)
Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
Chronic active viral hepatitis
Ejection fraction <50%
Respiratory failure necessitating supplemental oxygen
Parallel
TCRαβ Depleted haploidentical HCT
Procedure/SurgeryUse the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children
Incidence of grade II-IV acute GVHD
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
incidence of treatment related mortality(TRM)
compare the incidence of TRM until Day 100 post-transplantation
post HSCT day 1y and 2y GRFS and OS
compare the incidence of GRFS and OS post HSCT 1y and 2y
cGVHD post day 1y and 2y
compare the incidence of cGVHD post HSCT 1y and 2y
TRM post day +1y and +2y
compre the incidence of TRM post HSCT day 1y and 2y
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Sijia Gu
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor institution
