Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation

NCT06075563 | Recruiting

• 1 other identifier: PAED-2023-020
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Organs; Disorder

Outcome Measures

Primary Outcomes (1)

• Graft failure-free, GVHD-free survival

  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

  up to 1 year

Secondary Outcomes (8)

• Overall survival

  up to 1 year

• Proportion of patients who develop relapse among those with malignant diseases

  up to 1 year

• Proportion of patients who develop graft failure

  up to 1 year

• Proportion of patients who develop acute graft-versus-host disease

  up to 1 year

• Proportion of patients who develop chronic graft-versus-host disease

  up to 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Total lymphoid irradiation (TLI)

Radiation: Total lymphoid irradiation

Interventions

Total lymphoid irradiation RADIATION

Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant

Treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead
• The University of Hong Kong: collaborator
• Hong Kong Sanatorium & Hospital: collaborator

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Daniel Cheuk

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cheuk

CONTACT

852-35136049; cheukkld@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: May 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)