Using total lymphoid irradiation for pediatric stem cell transplantation
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
This study is testing whether total lymphoid irradiation can improve outcomes for kids receiving stem cell transplants compared to those getting standard total body irradiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Hong Kong Children's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06075563 on ClinicalTrials.gov |
What this trial studies
This study compares pediatric patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT) who receive total lymphoid irradiation (TLI) with age- and disease-matched controls receiving conventional total body irradiation (TBI). Participants will receive TLI via tomotherapy, delivering a total dose of 6Gy over two days, while the control group will have received TBI at varying doses. The study aims to evaluate outcomes such as graft failure-free survival, graft-versus-host disease (GVHD)-free survival, overall survival, and adverse effects. The goal is to determine the effectiveness and safety of TLI as a conditioning treatment in this patient population.
Who should consider this trial
Good fit: Ideal candidates are children aged 0-18 years requiring allogeneic HSCT with an HLA-haploidentical donor.
Not a fit: Patients with terminal malignancies and multiorgan failure or those for whom alternative treatments are more appropriate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce complications for pediatric patients undergoing stem cell transplantation.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using targeted irradiation techniques for conditioning in HSCT.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Hong Kong Children's Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Daniel Cheuk — Hong Kong Children's Hospital
- Study coordinator: Daniel Cheuk
- Email: cheukkld@gmail.com
- Phone: 852-35136049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.