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

Hematopoietic Organs; Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075563
• Other study ID #: PAED-2023-020
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Hong Kong Children's Hospital
• Contact: Daniel Cheuk
• Phone: 852-35136049
• Email: cheukkld[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Organs; Disorder

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Hong Kong Children's Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Hong Kong Children's Hospital	Hong Kong Sanatorium & Hospital, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	From the date of treatment start until the date of death from any cause, whichever comes first, assessed up to 1 year	up to 1 year
Secondary	Proportion of patients who develop relapse among those with malignant diseases	Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission	up to 1 year
Secondary	Proportion of patients who develop graft failure	Graft failure is defined as donor cells <5% in whole blood	up to 1 year
Secondary	Proportion of patients who develop acute graft-versus-host disease	Acute graft-versus-host disease is defined by MAGIC criteria	up to 1 year
Secondary	Proportion of patients who develop chronic graft-versus-host disease	Chronic graft-versus-host disease is defined by NIH criteria	up to 1 year
Secondary	Proportion of patients who develop adverse events not mentioned in outcomes 4-6	Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)	up to 1 year
Secondary	Blood T lymphocyte count at 3 months	Mean T lymphocyte count in blood among evaluable patients	at 3 months
Secondary	Blood T lymphocyte count at 1 year	Mean T lymphocyte count in blood among evaluable patients	at 1 year