RecruitingNot ApplicableNCT06075563

Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation


Sponsor

Hong Kong Children's Hospital

Enrollment

23 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In this comparative study, the investigators aim to compare prospective pediatric patients who receive total lymphoid irradiation (TLI) using tomotherapy with age- and disease-matched controls who receive conventional total body irradiation (TBI) as part of conditioning for haploidentical hematopoietic stem cell transplantation (HSCT) for both malignant and non-malignant diseases. The investigators shall evaluate graft failure-free, graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects and post-transplant immunoreconstitution.


Eligibility

Max Age: 18 Years

Inclusion Criteria3

  • Aged 0-18 years who requires allogeneic HSCT, has no human leukocyte antigen (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 Criteria4

  • Pregnant or lactating woman
  • HIV infection
  • Patients for whom alternative treatment is deemed more appropriate by treating physician
  • Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure

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Interventions

RADIATIONTotal lymphoid irradiation

Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant


Locations(1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

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NCT06075563


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