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

Hematopoietic Organs; Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034535
• Other study ID #: HKCH-REC-2022-002
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Hong Kong Children's Hospital
• Contact: Daniel Cheuk
• Phone: 85235136049
• Email: cheukkld[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Organs; Disorder

Intervention

Biological:
• CD62L depleted donor lymphocyte infusion
Intravenous infusion of CD62L depleted donor lymphocytes

Locations

Country	Name	City	State
Hong Kong	Hong Kong Children's Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Children's Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of patients who develop graft failure	Graft failure is defined as donor cells <5% in whole blood	up to 1 year
Secondary	Proportion of patients who develop infection	Any microbiologically documented infections are included	up to 1 year
Secondary	Proportion of patients who develop acute graft-versus-host disease	Acute graft-versus-host disease is defined by MAGIC criteria	up to 1 year
Secondary	Proportion of patients who develop chronic graft-versus-host disease	Chronic graft-versus-host disease is defined by NIH criteria	up to 1 year
Secondary	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
Secondary	Blood T lymphocyte count at 3 months	Mean T lymphocyte count in blood among evaluable patients	at 3 months
Secondary	Blood T lymphocyte count at 1 year	Mean T lymphocyte count in blood among evaluable patients	at 1 year