Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total lymphoid irradiation.
- Who it may be relevant to
- Registry conditions: Hematopoietic Organs; Disorder. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Radiotherapy at a dose of 6Gy divided into 3 equal fractions (2Gy per fraction) to all lymphoid organs (TLI) over 2 days using tomotherapy will be given to participants as part of the conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT). Retrospective patients who are age- and disease-matched with the recruited patients and had received radiotherapy to the whole body (TBI) with or without lung shielding at a total dose of 2-12 Gy delivered as 1-6 equal fractions by conventional opposed fields radiotherapy as part of conditioning will be compared for the outcomes.
Interventions
- Radiation Total lymphoid irradiation
Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
Primary outcome measures
- Graft failure-free, GVHD-free survival [Time frame: up to 1 year]
Secondary outcome measures (8)
- Overall survival [Time frame: up to 1 year]
- Proportion of patients who develop relapse among those with malignant diseases [Time frame: up to 1 year]
- Proportion of patients who develop graft failure [Time frame: up to 1 year]
- Proportion of patients who develop acute graft-versus-host disease [Time frame: up to 1 year]
- Proportion of patients who develop chronic graft-versus-host disease [Time frame: up to 1 year]
- Proportion of patients who develop adverse events not mentioned in outcomes 4-6 [Time frame: up to 1 year]
- Blood T lymphocyte count at 3 months [Time frame: at 3 months]
- Blood T lymphocyte count at 1 year [Time frame: at 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Hong Kong Children's Hospital — Hong Kong
Identifiers
NCT: NCT06075563 · PAED-2023-020