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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorHong Kong Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • CD62L depleted donor lymphocyte infusion

    Biological/Vaccine

    Intravenous infusion of CD62L depleted donor lymphocytes

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 1 year

Secondary outcomes

1

Overall survival

From the date of treatment start until the date of death from any cause, assessed up to 1 year

Time frame
up to 1 year
2

Proportion of patients who develop relapse among those with malignant diseases

Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission

Time frame
up to 1 year
3

Proportion of patients who develop graft failure

Graft failure is defined as donor cells \<5% in whole blood

Time frame
up to 1 year
4

Proportion of patients who develop infection

Any microbiologically documented infections are included

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

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