CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD62L depleted donor lymphocyte infusion.
- Who it may be relevant to
- Registry conditions: Hematopoietic Organs; Disorder. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Biological CD62L depleted donor lymphocyte infusion
Intravenous infusion of CD62L depleted donor lymphocytes
Primary outcome measures
- Graft failure-free, GVHD-free survival [Time frame: up to 1 year]
Secondary outcome measures (9)
- 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 infection [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 4-7 [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]
Eligibility criteria
Inclusion criteria
- Patient who requires allogeneic hematopoietic stem cell transplant, 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Hong Kong Children's Hospital — Hong Kong
Identifiers
NCT: NCT06034535 · HKCH-REC-2022-002