The goal of clinical trial is to compare the efficacy and safety of CD62L depleted donor lymphocyte infusion (DLI) with CD45RA depleted DLI in children who receive T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT).
Participants will be randomised to receive either CD62L depleted DLI or CD45RA depleted DLI with HSCT and evaluate for efficacy and safety outcomes.
Aged 0-18 years who requires allogeneic hematopoietic stem cell transplant, has no HLA-matched sibling donor but has an HLA-haploidentical donor.
Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy.
Karnofsky or Lansky performance status score ≥50
Pregnant or lactating woman
HIV infection
Patients for whom alternative treatment is deemed more appropriate
Patients who are unlikely to benefit from haploidentical HSCT, e.g., terminal malignancy with multiorgan failure
Parallel
CD62L depleted DLI
Biological/VaccineCD62L depleted DLI
CD45RA depleted DLI
Biological/VaccineCD45RA depleted DLI
Haploidentical HSCT
Procedure/SurgeryT cell depleted haploidentical HSCT
Frequency of viral infections
Frequency of composite CMV, EBV and/or ADV infections within 100 days of HSCT
Overall survival
Overall survival
disease-free survival
survival without underlying disease recurrence or progression
Frequency of acute GVHD
Frequency of acute GVHD
Cumulative incidence of chronic GVHD
Cumulative incidence of chronic GVHD
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