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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
| Hong Kong Sanatorium & Hospital | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Total lymphoid irradiation (TLI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total lymphoid irradiation | Radiation | Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of patients who develop relapse among those with malignant diseases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Cheuk | Contact | 852-35136049 | cheukkld@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cheuk | Hong Kong Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Children's Hospital | Recruiting | Hong Kong | Hong Kong |
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Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
| up to 1 year |
| Proportion of patients who develop graft failure | Graft failure is defined as donor cells <5% in whole blood | up to 1 year |
| Proportion of patients who develop acute graft-versus-host disease | Acute graft-versus-host disease is defined by MAGIC criteria | up to 1 year |
| Proportion of patients who develop chronic graft-versus-host disease | Chronic graft-versus-host disease is defined by NIH criteria | up to 1 year |
| 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 |
| Blood T lymphocyte count at 3 months | Mean T lymphocyte count in blood among evaluable patients | at 3 months |
| Blood T lymphocyte count at 1 year | Mean T lymphocyte count in blood among evaluable patients | at 1 year |