CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Study Details
Study Description
Brief Summary
In this clinical trial, we 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. We 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment CD62L depleted donor lymphocyte infusion |
Biological: CD62L depleted donor lymphocyte infusion
Intravenous infusion of CD62L depleted donor lymphocytes
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 graft failure [up to 1 year]
Graft failure is defined as donor cells <5% in whole blood
- Proportion of patients who develop infection [up to 1 year]
Any microbiologically documented infections are included
- 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 chronic graft-versus-host disease [up to 1 year]
Chronic graft-versus-host disease is defined by NIH criteria
- 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 3 months [at 3 months]
Mean T lymphocyte count in blood among evaluable patients
- Blood T lymphocyte count at 1 year [at 1 year]
Mean T lymphocyte count in blood among evaluable patients
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hong Kong Children's Hospital | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Hong Kong Children's Hospital
Investigators
- Principal Investigator: Daniel Cheuk, Hong Kong Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HKCH-REC-2022-002