Actively Recruiting
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Led by Hong Kong Children's Hospital · Updated on 2025-09-15
23
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is studying patients with malignant or non-malignant diseases who need a hematopoietic stem cell transplant (HSCT) but do not have a fully matched sibling donor. The researchers aim to evaluate the use of CD62L depleted donor lymphocyte infusion combined with T cell receptor alpha-beta depleted haploidentical HSCT. The goal is to assess survival without graft failure or graft-versus-host disease (GVHD) at one year, as well as monitor adverse events, complications, and immune recovery. The treatment involves collecting peripheral stem cells from a related haploidentical donor, dividing the product into two parts: one undergoing T cell receptor alpha-beta depletion and the other CD62L depletion. Both depleted products are then infused intravenously into the patient on the same day. This approach is being studied in a phase 2 trial to evaluate its potential benefits and risks. Participants will be followed for up to one year after transplantation. Researchers will monitor graft failure-free and GVHD-free survival, overall survival, relapse rates, infections, acute and chronic GVHD, and other adverse events during this period. They will also assess blood T lymphocyte counts at 3 months and 1 year to evaluate immune system recovery. The trial includes patients up to 18 years old and involves careful safety and outcome monitoring throughout the study.
CONDITIONS
Brief Title
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requires allogeneic hematopoietic stem cell transplant and has no HLA-matched sibling donor but has an HLA-haploidentical donor
- Adequate organ function to tolerate conditioning chemotherapy and radiotherapy
- Karnofsky or Lansky performance status score of 50 or higher
You will not qualify if you...
- Pregnant or lactating women
- HIV infection
- Patients for whom alternative treatment is deemed more appropriate by treating physician
- Patients unlikely to benefit from haploidentical hematopoietic stem cell transplantation, such as those with terminal malignancy and multiorgan failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive CD62L depleted donor lymphocyte infusion along with T cell receptor αβ depleted hematopoietic stem cell transplantation on the same day.
1 infusion visit (in-person)
Duration - Up to 1 year
Participants are monitored for graft failure, graft-versus-host disease, relapse, infections, adverse events, and overall survival up to 1 year after treatment.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Daniel Cheuk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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