Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
- Conditions
- Hematopoietic Organs; Disorder
- Interventions
- Radiation: Total lymphoid irradiation
- Registration Number
- NCT06075563
- Lead Sponsor
- Hong Kong Children's Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Total lymphoid irradiation Total lymphoid irradiation (TLI)
- Primary Outcome Measures
Name Time Method Graft failure-free, GVHD-free survival 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 Outcome Measures
Name Time Method Proportion of patients who develop relapse among those with malignant diseases up to 1 year Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
Proportion of patients who develop acute graft-versus-host disease up to 1 year Acute graft-versus-host disease is defined by MAGIC criteria
Proportion of patients who develop graft failure up to 1 year Graft failure is defined as donor cells \<5% in whole blood
Proportion of patients who develop chronic graft-versus-host disease up to 1 year Chronic graft-versus-host disease is defined by NIH criteria
Overall survival 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 adverse events not mentioned in outcomes 4-6 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 at 3 months Mean T lymphocyte count in blood among evaluable patients
Blood T lymphocyte count at 1 year at 1 year Mean T lymphocyte count in blood among evaluable patients
Trial Locations
- Locations (1)
Hong Kong Children's Hospital
🇭🇰Hong Kong, Hong Kong