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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorHong Kong Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Total lymphoid irradiation

    Radiation

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

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

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

Time frame
up to 1 year

Secondary outcomes

1

Overall survival

From the date of treatment start until the date of death from any cause, whichever comes first, assessed up to 1 year

Time frame
up to 1 year
2

Proportion of patients who develop relapse among those with malignant diseases

Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission

Time frame
up to 1 year
3

Proportion of patients who develop graft failure

Graft failure is defined as donor cells \<5% in whole blood

Time frame
up to 1 year
4

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

Acute graft-versus-host disease is defined by MAGIC criteria

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Children's Hospital

Lead sponsor

The University of Hong Kong

Collaborator

Hong Kong Sanatorium & Hospital

Collaborator