Who may be eligible for this hematopoietic organ disorder clinical trial?

Patients up to 18 years old who require an allogeneic stem cell transplant and do not have an HLA-matched sibling donor but have an HLA-haploidentical donor may be eligible. They must have adequate organ function and a performance status score of 50 or higher. Please review eligibility criteria for more details.

Is there any cost to participate in this hematopoietic organ disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 0 - 18Years

All Genders

ID06034535

Treatment Using CD62L Depleted Donor Lymphocyte Infusion and T Cell Depleted Haploidentical Stem Cell Transplantation for Blood Disorders

Q: What is CD62L depleted donor lymphocyte infusion studying for hematopoietic organ disorders?

This clinical trial is evaluating a new way to help patients who need a stem cell transplant but do not have a fully matched donor. Researchers are studying the use of CD62L depleted donor lymphocyte infusion combined with special T cell depletion techniques to improve transplant outcomes and reduce complications. The study is led by the Hong Kong Children's Hospital.

Led by Hong Kong Children's Hospital · Updated on 2025-09-15

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This clinical trial is studying patients with malignant or non-malignant diseases who need a hematopoietic stem cell transplant HSCT but do not have a fully matched sibling donor. The researchers aim to evaluate the use of CD62L depleted donor lymphocyte infusion combined with T cell receptor alpha-beta depleted haploidentical HSCT. The goal is to assess survival without graft failure or graft-versus-host disease GVHD at one year, as well as monitor adverse events, complications, and immune recovery. The treatment involves collecting peripheral stem cells from a related haploidentical donor, dividing the product into two parts one undergoing T cell receptor alpha-beta depletion and the other CD62L depletion. Both depleted products are then infused intravenously into the patient on the same day. This approach is being studied in a phase 2 trial to evaluate its potential benefits and risks. Participants will be followed for up to one year after transplantation. Researchers will monitor graft failure-free and GVHD-free survival, overall survival, relapse rates, infections, acute and chronic GVHD, and other adverse events during this period. They will also assess blood T lymphocyte counts at 3 months and 1 year to evaluate immune system recovery. The trial includes patients up to 18 years old and involves careful safety and outcome monitoring throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Patient requires allogeneic hematopoietic stem cell transplant and has no HLA-matched sibling donor but has an HLA-haploidentical donor
Adequate organ function to tolerate conditioning chemotherapy and radiotherapy
Karnofsky or Lansky performance status score of 50 or higher

You will not qualify if you...

Pregnant or lactating women
HIV infection
Patients for whom alternative treatment is deemed more appropriate by treating physician
Patients unlikely to benefit from haploidentical hematopoietic stem cell transplantation, such as those with terminal malignancy and multiorgan failure

Research Team

Daniel Cheuk

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