About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Total lymphoid irradiation
RadiationTotal lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
Treatment groups
Trial outcomes
Primary outcomes
Graft failure-free, GVHD-free survival
From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year
Secondary outcomes
Overall survival
From the date of treatment start until the date of death from any cause, whichever comes first, assessed up to 1 year
Proportion of patients who develop relapse among those with malignant diseases
Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
Proportion of patients who develop graft failure
Graft failure is defined as donor cells \<5% in whole blood
Proportion of patients who develop acute graft-versus-host disease
Acute graft-versus-host disease is defined by MAGIC criteria
Sponsors and contacts
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Hong Kong Children's Hospital
Lead sponsor
The University of Hong Kong
Collaborator
Hong Kong Sanatorium & Hospital
Collaborator