Hematopoietic Organs; Disorder
Conditions
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.
Detailed 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.
Interventions
BIOLOGICALCD62L depleted donor lymphocyte infusion
Intravenous infusion of CD62L depleted donor lymphocytes
Sponsors
Hong Kong Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft failure-free, GVHD-free survival | up to 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who develop relapse among those with malignant diseases | up to 1 year | Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission |
| Proportion of patients who develop graft failure | up to 1 year | Graft failure is defined as donor cells \<5% in whole blood |
| Proportion of patients who develop infection | up to 1 year | Any microbiologically documented infections are included |
| Proportion of patients who develop acute graft-versus-host disease | up to 1 year | Acute graft-versus-host disease is defined by MAGIC criteria |
| Overall survival | up to 1 year | From the date of treatment start until the date of death from any cause, assessed up to 1 year |
| Proportion of patients who develop adverse events not mentioned in outcomes 4-7 | up to 1 year | Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) |
| Blood T lymphocyte count at 3 months | at 3 months | Mean T lymphocyte count in blood among evaluable patients |
| Blood T lymphocyte count at 1 year | at 1 year | Mean T lymphocyte count in blood among evaluable patients |
| Proportion of patients who develop chronic graft-versus-host disease | up to 1 year | Chronic graft-versus-host disease is defined by NIH criteria |
Countries
Hong Kong
Contacts
Primary ContactDaniel Cheuk
Outcome results
None listed