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

NCT06034535 | Recruiting Phase 2

• 1 other identifier: HKCH-REC-2022-002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Organs; Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Overall survival

  up to 1 year

• Proportion of patients who develop relapse among those with malignant diseases

  up to 1 year

• Proportion of patients who develop graft failure

  up to 1 year

• Proportion of patients who develop infection

  up to 1 year

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

  up to 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

CD62L depleted donor lymphocyte infusion

Biological: CD62L depleted donor lymphocyte infusion

Interventions

CD62L depleted donor lymphocyte infusion BIOLOGICAL

Intravenous infusion of CD62L depleted donor lymphocytes

Treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Daniel Cheuk

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cheuk

CONTACT

85235136049; cheukkld@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)