A Phase 2 interventional study of CD62L depleted DLI and CD45RA depleted DLI in Hematopoietic Cell Transplantation, 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 2026-10-09.
Sponsored by Hong Kong Children's Hospital · Phase 2, Interventional, and Treatment
The goal of clinical trial is to compare the efficacy and safety of CD62L depleted donor lymphocyte infusion (DLI) with CD45RA depleted DLI in children who receive T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT).
Participants will be randomised to receive either CD62L depleted DLI or CD45RA depleted DLI with HSCT and evaluate for efficacy and safety outcomes.
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the standard therapy for many malignant and non-malignant diseases in children. For patients lacking human leukocyte antigen (HLA)-matched donor, HLA-haploidentical family donor is an increasingly used alternative. In vitro T cell depletion can minimize graft-versus-host disease (GVHD) but increase the risk of infections, graft rejection and relapse of malignancy. CD45RA depleted donor lymphocyte infusion (DLI) can reduce these risks while reducing the risk of GVHD by removing naïve T cells but retaining memory T cells, and is currently one of the standard therapeutic options. The newly developed CD62L depletion may be an even better option that further reduces the risk of infection and GVHD as terminally differentiated CD45RA positive T cells (TEMRA) is retained while central memory T cells are depleted. In this randomized controlled trial, we aim to compare CD62L depleted DLI with CD45RA depleted DLI, in the context of T cell depleted haploidentical HSCT to treat children with malignant or non-malignant disease in need of HSCT. We shall evaluate the frequency of composite viral infections within 100 days of HSCT, overall and disease-free survivals, frequency of acute GVHD, and cumulative incidence of chronic GVHD, malignancy relapse, graft failure and other adverse effects.
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.
CD62L depleted DLI
Biological: CD62L depleted DLI · Procedure: Haploidentical HSCT
CD45RA depleted DLI
Biological: CD45RA depleted DLI · Procedure: Haploidentical HSCT
CD62L depleted DLI
CD45RA depleted DLI
T cell depleted haploidentical HSCT
Frequency of viral infections
Frequency of composite CMV, EBV and/or ADV infections within 100 days of HSCT
Time frame: within 100 days after HSCT
Overall survival
Overall survival
Time frame: 1 year
disease-free survival
survival without underlying disease recurrence or progression
Time frame: 1 year
Frequency of acute GVHD
Frequency of acute GVHD
Time frame: 100 days
Cumulative incidence of chronic GVHD
Cumulative incidence of chronic GVHD
Time frame: 1 year
Cumulative incidence of relapse of malignancy
Cumulative incidence of relapse of malignancy
Time frame: 1 year
Cumulative incidence of graft failure
Cumulative incidence of graft failure
Time frame: 1 year
Cumulative incidence of other adverse effects
Cumulative incidence of other adverse effects
Time frame: 1 year
Plan to share: Yes — Anonymized outcome data
Supporting information: Study protocol, Informed consent form
Time frame: IPD will be available from the time of publication till 1 Oct 2032 (3 years after end of study)
Access criteria: Publisher and authorized people will be able to access individual anonymized outcome data by email
Started Oct 2026 (actual). Primary completion is estimated for Oct 2029, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hong Kong Children's Hospital