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

Phase 2RecruitingNCT06034535

Hong Kong Children's Hospital23 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematopoietic Organs; Disorder

Interventions

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 1 year

Secondary Outcomes

Overall survival

From the date of treatment start until the date of death from any cause, assessed up to 1 year

Time frame: 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

Time frame: up to 1 year

Proportion of patients who develop graft failure

Graft failure is defined as donor cells \<5% in whole blood

Time frame: up to 1 year

Proportion of patients who develop infection

Any microbiologically documented infections are included

Time frame: up to 1 year

Proportion of patients who develop acute graft-versus-host disease

Acute graft-versus-host disease is defined by MAGIC criteria

Time frame: up to 1 year

Proportion of patients who develop chronic graft-versus-host disease

Chronic graft-versus-host disease is defined by NIH criteria

Time frame: 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)

Time frame: up to 1 year

Blood T lymphocyte count at 3 months

Mean T lymphocyte count in blood among evaluable patients

Time frame: at 3 months

Blood T lymphocyte count at 1 year

Mean T lymphocyte count in blood among evaluable patients

Time frame: at 1 year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts