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NCT07867769
Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Conditions: Hematopoietic Cell Transplantation
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 46
Sponsor: Hong Kong Children's Hospital
Location: Hong Kong Children's Hospital Hong Kong
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07867769). StuddyBuddy aggregates publicly available trial information.