A Phase 2 interventional study of CD62L depleted donor lymphocyte infusion 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 2025-09-15.
Sponsored by Hong Kong Children's Hospital · Phase 2, Interventional, and Treatment
In this clinical trial, the investigators aim to apply CD62L depleted donor lymphocyte infusion (DLI) together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. The investigators shall evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year, frequency of adverse events and post-transplant complications, and immunoreconstitution.
The peripheral stem cell harvest product from the patient's related haploidential donor will be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and the other portion will undergo CD62L depletion. Both depleted products will be infused intravenously to the patient on the same day.
Hong Kong Children's Hospital is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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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.
CD62L depleted donor lymphocyte infusion
Biological: CD62L depleted donor lymphocyte infusion
Intravenous infusion of CD62L depleted donor lymphocytes
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, 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 infection
Any microbiologically documented infections are included
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 4-7
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 Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.
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Hong Kong Children's Hospital