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Recruiting NCT05066412

Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

Phase I Interventional Hematologic Malignancy Haplo-identical Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology.
Who it may be relevant to
Registry conditions: Hematologic Malignancy, Haplo-identical Stem Cell Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning

Overview

To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

Detailed description

Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.

Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.

Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.

Interventions

  • Other CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
    CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Primary outcome measures

  • acute transfusion reaction (CTCAE ≥ 2) [Time frame: 24 hours after each CD45RA neg DLI infusion]
  • acute GvHD grade II-IV [Time frame: within 8 weeks after each CD45RAneg DLI infusion]

Eligibility criteria

Inclusion criteria

  • Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
  • Written informed consent of patient and donor obtained

Exclusion criteria

  • Participant taking Prednisone (or equivalent steroid)
  • Participant taking Prednisone (or equivalent steroid)
  • Participant taking Mycophenolate Mofetil
  • Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
  • Progressive hematologic malignancy before transplant
  • Second allogeneic transplant
  • Acute GvHD ≥ grade 2
  • Chronic moderate or severe GvHD (NIH consensus criteria)
  • Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
  • Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
  • Participation in another interventional clinical trial within 30 days prior to inclusion
  • Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
  • Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • HUG — Geneva

Identifiers

NCT: NCT05066412 · Cd45RA depleted DLI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗