Clinical trial NCT06034535: CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Official title: CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematopoietic Organs; Disorder
Lead sponsor: Hong Kong Children's Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 23
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Graft failure-free, GVHD-free survival
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: up to 1 year
measure: Proportion of patients who develop relapse among those with malignant diseases
timeFrame: up to 1 year
measure: Proportion of patients who develop graft failure
timeFrame: up to 1 year
measure: Proportion of patients who develop infection
timeFrame: up to 1 year
measure: Proportion of patients who develop acute graft-versus-host disease
timeFrame: up to 1 year
measure: Proportion of patients who develop chronic graft-versus-host disease
timeFrame: up to 1 year
measure: Proportion of patients who develop adverse events not mentioned in outcomes 4-7
timeFrame: up to 1 year
measure: Blood T lymphocyte count at 3 months
timeFrame: at 3 months
measure: Blood T lymphocyte count at 1 year
timeFrame: at 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Children's Hospital
Study officials:
affiliation: Hong Kong Children's Hospital
name: Daniel Cheuk
role: PRINCIPAL_INVESTIGATOR
References: