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Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

Sponsor
University Hospital, Geneva (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05066412
Collaborator
(none)
12
Enrollment
1
Arm
61.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Jun 2, 2026
Anticipated Study Completion Date :
Dec 2, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Prophylactic CD45RA-depleted DLI

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

Outcome Measures

Primary Outcome Measures

  1. acute transfusion reaction (CTCAE ≥ 2) [24 hours after each CD45RA neg DLI infusion]

    acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)

  2. acute GvHD grade II-IV [within 8 weeks after each CD45RAneg DLI infusion]

    acute GvHD grade II-IV measured with MAGIC score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne-Claire Mamez, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT05066412
Other Study ID Numbers:
  • Cd45RA depleted DLI
First Posted:
Oct 4, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hematologic Neoplasms

Study Results

No Results Posted as of Oct 4, 2021