Hong Kong Children's Hospital
Hong Kong
Location status: Recruiting
Recruiting
NCT Number: NCT06075563
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
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.
Recruiting
Interested in participating?
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Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Total lymphoid irradiation
RadiationTotal lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
Primary outcomes
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Graft failure-free, GVHD-free survival
Time frame: up to 1 year
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
Time frame: up to 1 year
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
Time frame: up to 1 year
Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
-
Proportion of patients who develop graft failure
Time frame: up to 1 year
Graft failure is defined as donor cells <5% in whole blood
-
Proportion of patients who develop acute graft-versus-host disease
Time frame: up to 1 year
Acute graft-versus-host disease is defined by MAGIC criteria
-
Proportion of patients who develop chronic graft-versus-host disease
Time frame: up to 1 year
Chronic graft-versus-host disease is defined by NIH criteria
-
Proportion of patients who develop adverse events not mentioned in outcomes 4-6
Time frame: up to 1 year
Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)
-
Blood T lymphocyte count at 3 months
Time frame: at 3 months
Mean T lymphocyte count in blood among evaluable patients
-
Blood T lymphocyte count at 1 year
Time frame: at 1 year
Mean T lymphocyte count in blood among evaluable patients
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hong Kong Children's Hospital
Other
Collaborators
- Hong Kong Sanatorium & Hospital
- The University of Hong Kong
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Oct 10, 2023
- Registry last updated
- Sep 10, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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