Actively Recruiting
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
Led by Hong Kong Children's Hospital · Updated on 2025-09-10
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hong Kong Children's Hospital
Lead Sponsor
T
The University of Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating total lymphoid irradiation (TLI) using tomotherapy as a conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT) in children aged 0 to 18 years. This study compares TLI with conventional total body irradiation (TBI) given to similar pediatric patients with malignant and non-malignant blood disorders. The purpose is to assess outcomes like graft failure-free and graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects, and immune recovery after transplant. Participants receiving TLI will get a total dose of 6 Gy divided into three fractions over two days targeting all lymphoid organs using tomotherapy. The comparison group includes retrospective patients matched by age and disease who received TBI with doses ranging from 2 to 12 Gy in 1 to 6 fractions by conventional radiotherapy methods with or without lung shielding. Both treatments are part of the conditioning before the stem cell transplant. During the study, researchers will monitor participants up to one year after transplant for graft failure-free and GVHD-free survival as the primary outcome. Secondary outcomes include overall survival, relapse rates for malignant diseases, acute and chronic GVHD incidence, other adverse events, and blood T lymphocyte counts at 3 months and 1 year. The study involves regular assessments to evaluate transplant success, complications, and immune system recovery.
CONDITIONS
Brief Title
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 0 to 18 years requiring allogeneic hematopoietic stem cell transplantation
- No HLA-matched sibling donor but has an HLA-haploidentical donor
- Adequate organ function to tolerate conditioning chemotherapy and radiotherapy
- Karnofsky or Lansky performance status score of 50 or higher
You will not qualify if you...
- Pregnant or lactating women
- HIV infection
- Patients for whom alternative treatment is considered more appropriate by the physician
- Patients unlikely to benefit from haploidentical hematopoietic stem cell transplantation, such as those with terminal malignancy and multiorgan failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants receive total lymphoid irradiation (TLI) at a dose of 6Gy divided into 3 equal fractions over 2 days as conditioning before haploidentical hematopoietic stem cell transplantation.
3 visits (in-person) for irradiation sessions
Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Daniel Cheuk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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