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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

PHASE2RECRUITING

A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.

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Study details:

Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • The participant is aged ≥ 16 and deemed medically fit per investigator for protocol
  • The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome
  • The participant will receive a blood progenitor cell graft ("HPC, Apheresis")
  • The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.
  • The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.
  • The participant has good performance status (Karnofsky ≥60%)
  • The participant is able to understand and sign the informed consent form
  • Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.
  • The participant is receiving their first transplant
  • Exclusion criteria

  • The participant is HIV antibody positive
  • The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.
  • The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)
  • The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
  • The participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
  • The participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
  • The participant has urinary outflow obstruction
  • The participant is in poor condition (determined per institutional guidelines)
  • The participant has acute leukemia in relapse
  • The participant has myelodysplastic syndrome with > 10% marrow blasts
  • The participant is having their second transplant
  • The participant is taking T-cell antibody prophylaxis (anti-CD52)
  • The participant is receiving a cord blood graft or T-cell depleted grafts
  • The participant has mixed phenotype acute leukemia
  • The participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the sponsors.
  • The participant is in complete remission with incomplete recovery (CRi)
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    Eligibility

    Age eligible for study : 16 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2020-10-13

    Primary completion: 2024-10-13

    Study completion finish: 2024-12-31

    study type

    Study type

    PREVENTION

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT04202835

    Intervention or treatment

    DRUG: Cyclophosphamide

    DRUG: Anti-Thymocyte globulin (rabbit)

    Conditions

    • Acute Leukemia
    • Myelodysplasia
    • Chronic Graft-versus-host-disease
    Image related to Acute Leukemia
    • Condition: Acute Leukemia, Myelodysplasia and more

    • DRUG: Cyclophosphamide and other drugs

    • Darlinghurst, New South Wales, Australia and more

    • Sponsor: McMaster University

    Find a site

    Closest Location:

    Kinghorn Cancer Centre, St Vincent's Health Network

    Research sites nearby

    Select from list below to view details:

    • Kinghorn Cancer Centre, St Vincent's Health Network

      Darlinghurst, New South Wales, Australia

    • Royal North Shore Hospital

      St. Leonards, New South Wales, Australia

    • Australasian Leukaemia and Lymphoma Group

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: ATG/PTCy
    • Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.
    DRUG: Cyclophosphamide
    • Post Transplant Cyclophosphamide
    ACTIVE_COMPARATOR: ATG
    • Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).
    DRUG: Anti-Thymocyte globulin (rabbit)
    • Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Registration of 80 patients within twenty four monthsRegistration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)24 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    CRFSChronic graft versus host disease free- and relapse-free survival (CRFS)27 months
    GRFSGraft versus host disease-, and relapse-, free survival (GRFS)27 months
    SurvivalSurvival (dead/alive) at 100 days for each patient27 months
    Complete data collectionThe Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection27 months
    Cost of studyThe sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget.27 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: ATG Plus PTCy vs ATG for CGVHD Prophylaxis

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