Hematopoietic Organs; DisorderNCT06075563
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
A study testing Total lymphoid irradiation in people with Hematopoietic Organs; Disorder, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hematopoietic Organs; Disorder
- What is being tested?
- Total lymphoid irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Daniel Cheuk, 852-35136049, cheukkld@gmail.com
About this study
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.
Read the 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.
- Conditions
- Hematopoietic Organs; Disorder
- Being tested
- Total lymphoid irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total lymphoid irradiationRadiation
Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Total lymphoid irradiation (TLI) Receives: Radiation: Total lymphoid irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
Secondary outcomes (8)
Overall survival
From the date of treatment start until the date of death from any cause, whichever comes first, assessed up to 1 year
Measured: 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
Measured: up to 1 year
Proportion of patients who develop graft failure
Graft failure is defined as donor cells <5% in whole blood
Measured: up to 1 year
Proportion of patients who develop acute graft-versus-host disease
Acute graft-versus-host disease is defined by MAGIC criteria
Measured: up to 1 year
Proportion of patients who develop chronic graft-versus-host disease
Chronic graft-versus-host disease is defined by NIH criteria
Measured: 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)
Measured: up to 1 year
Blood T lymphocyte count at 3 months
Mean T lymphocyte count in blood among evaluable patients
Measured: at 3 months
Blood T lymphocyte count at 1 year
Mean T lymphocyte count in blood among evaluable patients
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start29 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Organs; DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Hong Kong Sanatorium & Hospital
- Responsible party
- Sponsor
- Investigators
- Daniel Cheuk, Principal investigator, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075563
- Sponsor's protocol ID
- PAED-2023-020
- Status last verified
- Mar 2025
- First submitted
- 4 Oct 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06075563
- Acronym / sponsor ID
- PAED-2023-020
- Conditions
- Hematopoietic Organs; Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Hong Kong Sanatorium & Hospital
- Study start
- 29 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Total lymphoid irradiationTotal lymphoid irradiation (TLI) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total lymphoid irradiationTotal lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant | Radiation | Treatment |
Primary outcome
Graft failure-free, GVHD-free survival
Time frame: 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
8 secondary outcomes
Overall survival
Time frame: up to 1 year
Proportion of patients who develop relapse among those with malignant diseases
Time frame: up to 1 year
Proportion of patients who develop graft failure
Time frame: up to 1 year
Proportion of patients who develop acute graft-versus-host disease
Time frame: up to 1 year
Proportion of patients who develop chronic graft-versus-host disease
Time frame: up to 1 year
Proportion of patients who develop adverse events not mentioned in outcomes 4-6
Time frame: up to 1 year
Blood T lymphocyte count at 3 months
Time frame: at 3 months
Blood T lymphocyte count at 1 year
Time frame: at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Cheuk principal investigator
Hong Kong Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total lymphoid irradiation in people with Hematopoietic Organs; Disorder, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Cheuk (852-35136049, cheukkld@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure-free, GVHD-free survival (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.