CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
- Conditions
- Hematopoietic Organs; Disorder
- Interventions
- Biological: CD62L depleted donor lymphocyte infusion
- Registration Number
- NCT06034535
- Lead Sponsor
- Hong Kong Children's Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment CD62L depleted donor lymphocyte infusion CD62L depleted donor lymphocyte infusion
- Primary Outcome Measures
Name Time Method Graft failure-free, GVHD-free survival up to 1 year 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
- Secondary Outcome Measures
Name Time Method Proportion of patients who develop graft failure up to 1 year Graft failure is defined as donor cells \<5% in whole blood
Proportion of patients who develop acute graft-versus-host disease up to 1 year Acute graft-versus-host disease is defined by MAGIC criteria
Proportion of patients who develop infection up to 1 year Any microbiologically documented infections are included
Proportion of patients who develop chronic graft-versus-host disease up to 1 year Chronic graft-versus-host disease is defined by NIH criteria
Blood T lymphocyte count at 3 months at 3 months Mean T lymphocyte count in blood among evaluable patients
Overall survival up to 1 year From the date of treatment start until the date of death from any cause, assessed up to 1 year
Proportion of patients who develop relapse among those with malignant diseases up to 1 year Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
Proportion of patients who develop adverse events not mentioned in outcomes 4-7 up to 1 year Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)
Blood T lymphocyte count at 1 year at 1 year Mean T lymphocyte count in blood among evaluable patients
Trial Locations
- Locations (1)
Hong Kong Children's Hospital
🇭🇰Hong Kong, Hong Kong