search
Back to results

Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

Primary Purpose

Hematologic Malignancy, Haplo-identical Stem Cell Transplantation

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Prophylactic CD45RA-depleted DLI

    Outcomes

    Primary Outcome Measures

    acute transfusion reaction (CTCAE ≥ 2)
    acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
    acute GvHD grade II-IV
    acute GvHD grade II-IV measured with MAGIC score

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2021
    Last Updated
    October 1, 2021
    Sponsor
    University Hospital, Geneva
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05066412
    Brief Title
    Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2021 (Anticipated)
    Primary Completion Date
    June 2, 2026 (Anticipated)
    Study Completion Date
    December 2, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Geneva

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematologic Malignancy, Haplo-identical Stem Cell Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Prophylactic CD45RA-depleted DLI
    Intervention Type
    Other
    Intervention Name(s)
    CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
    Intervention Description
    CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
    Primary Outcome Measure Information:
    Title
    acute transfusion reaction (CTCAE ≥ 2)
    Description
    acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
    Time Frame
    24 hours after each CD45RA neg DLI infusion
    Title
    acute GvHD grade II-IV
    Description
    acute GvHD grade II-IV measured with MAGIC score
    Time Frame
    within 8 weeks after each CD45RAneg DLI infusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

    We'll reach out to this number within 24 hrs