Hematopoietic Organs; Disorder Clinical Trial
Official title:
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
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.
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Hong Kong Children's Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hong Kong Children's Hospital |
Hong Kong,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06075563 -
Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
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Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
|
Phase 1 |