Hematopoietic Organs; Disorder
Conditions
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.
Interventions
RADIATIONTotal lymphoid irradiation
Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
Sponsors
The University of Hong Kong
Hong Kong Sanatorium & Hospital
Hong Kong Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 graft failure | up to 1 year | Graft failure is defined as donor cells \<5% in whole blood |
| Proportion of patients who develop acute graft-versus-host disease | up to 1 year | Acute graft-versus-host disease is defined by MAGIC 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 |
| Proportion of patients who develop chronic graft-versus-host disease | up to 1 year | Chronic graft-versus-host disease is defined by NIH criteria |
Countries
Hong Kong
Contacts
Primary ContactDaniel Cheuk
Outcome results
None listed