Infusion of specialized donor lymphocytes after stem cell transplant
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
PHASE2 · Hong Kong Children's Hospital · NCT06034535
This study is testing if a special type of donor immune cells can help patients with different diseases recover better after receiving a stem cell transplant.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Hong Kong Children's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06034535 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of CD62L depleted donor lymphocyte infusion in conjunction with T cell depleted haploidentical hematopoietic stem cell transplantation to treat patients with various malignant or non-malignant diseases. The study aims to assess the effectiveness of this approach by evaluating graft failure-free and graft-versus-host disease-free survival rates at one year, as well as monitoring adverse events and post-transplant complications. The trial involves the collection of stem cells from a related haploidentical donor, which are then processed to remove specific T cells before being infused into the patient on the same day.
Who should consider this trial
Good fit: Ideal candidates include patients needing an allogeneic hematopoietic stem cell transplant who have an HLA-haploidentical donor available.
Not a fit: Patients with terminal malignancies and multiorgan failure, or those for whom alternative treatments are more appropriate, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve transplant outcomes and reduce complications for patients requiring stem cell transplants.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving transplant outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Hong Kong Children's Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Daniel Cheuk — Hong Kong Children's Hospital
- Study coordinator: Daniel Cheuk
- Email: cheukkld@gmail.com
- Phone: 85235136049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematopoietic Organs, Disorder