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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | CD62L depleted donor lymphocyte infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD62L depleted donor lymphocyte infusion | Biological | Intravenous infusion of CD62L depleted donor lymphocytes |
|
| 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, 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 | 85235136049 | 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 infection | Any microbiologically documented infections are included | 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 4-7 | 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 |