About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
CD62L depleted donor lymphocyte infusion
Biological/VaccineIntravenous infusion of CD62L depleted donor lymphocytes
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Overall survival
From the date of treatment start until the date of death from any cause, assessed up to 1 year
Proportion of patients who develop relapse among those with malignant diseases
Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
Proportion of patients who develop graft failure
Graft failure is defined as donor cells \<5% in whole blood
Proportion of patients who develop infection
Any microbiologically documented infections are included
Sponsors and contacts
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