An interventional study of Total lymphoid irradiation in Hematopoietic Organs; Disorder, sponsored by Hong Kong Children's Hospital. Recruiting at 1 site in Hong Kong. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Hong Kong Children's Hospital · Not applicable, Interventional, and Treatment
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.
Hong Kong Children's Hospital is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total lymphoid irradiation (TLI)
Radiation: Total lymphoid irradiation
Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
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
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
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
Proportion of patients who develop graft failure
Graft failure is defined as donor cells \<5% in whole blood
Time frame: up to 1 year
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
Proportion of patients who develop chronic graft-versus-host disease
Chronic graft-versus-host disease is defined by NIH criteria
Time frame: 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)
Time frame: up to 1 year
Blood T lymphocyte count at 3 months
Mean T lymphocyte count in blood among evaluable patients
Time frame: at 3 months
Blood T lymphocyte count at 1 year
Mean T lymphocyte count in blood among evaluable patients
Time frame: at 1 year
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hong Kong Children's Hospital