CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation

Conditions
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Hematopoietic Organs; Disorder

Intervention / Treatment
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* Biological: CD62L depleted donor lymphocyte infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>CD62L depleted donor lymphocyte infusion | Biological: CD62L depleted donor lymphocyte infusion<br>* Intravenous infusion of CD62L depleted donor lymphocytes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |