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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

Sponsor
McMaster University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04202835
Collaborator
Cell Therapy Transplant Canada (Other), Sanofi (Industry), Ozmosis Research Inc. (Industry)
80
Enrollment
9
Locations
2
Arms
50.6
Anticipated Duration (Months)
8.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized pilot trialRandomized pilot trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD)
Actual Study Start Date :
Oct 13, 2020
Anticipated Primary Completion Date :
Oct 13, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/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

Drug: Anti-Thymocyte globulin (rabbit)
Anti-Thymocyte Globulin (rabbit, Thymoglobulin)
Other Names:
  • Thymoglobulin

    		•
    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)
    Other Names:
  • Thymoglobulin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Registration of 80 patients within twenty four months [24 months]

      Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)

    Secondary Outcome Measures

    1. CRFS [27 months]

      Chronic graft versus host disease free- and relapse-free survival (CRFS)

    2. GRFS [27 months]

      Graft versus host disease-, and relapse-, free survival (GRFS)

    3. Survival [27 months]

      Survival (dead/alive) at 100 days for each patient

    4. Complete data collection [27 months]

      The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection

    5. Cost of study [27 months]

      The 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The participant is aged ≥ 16 and deemed medically fit per investigator for protocol

    2. The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome

    3. The participant will receive a blood progenitor cell graft ("HPC, Apheresis")

    4. The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.

    5. The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.

    6. The participant has good performance status (Karnofsky ≥60%)

    7. The participant is able to understand and sign the informed consent form

    8. Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.

    9. The participant is receiving their first transplant

    Exclusion Criteria:

    1. The participant is HIV antibody positive

    2. The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.

    3. The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)

    4. The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment

    5. 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

    6. 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

    7. The participant has urinary outflow obstruction

    8. The participant is in poor condition (determined per institutional guidelines)

    9. The participant has acute leukemia in relapse

    10. The participant has myelodysplastic syndrome with > 10% marrow blasts

    11. The participant is having their second transplant

    12. The participant is taking T-cell antibody prophylaxis (anti-CD52)

    13. The participant is receiving a cord blood graft or T-cell depleted grafts

    14. The participant has mixed phenotype acute leukemia

    15. 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.

    16. The participant is in complete remission with incomplete recovery (CRi)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kinghorn Cancer Centre, St Vincent's Health Network Darlinghurst New South Wales Australia 2010
    2 Royal North Shore Hospital St. Leonards New South Wales Australia 2065
    3 Australasian Leukaemia and Lymphoma Group Melbourne Victoria Australia 3121
    4 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    5 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H 2Y9
    6 Juravinski Hospital and Cancer Centre Hamilton Ontario Canada L8V 1C3
    7 London Health Sciences Centre London Ontario Canada N6A 5W9
    8 Hôpital de l'Enfant-Jésus Québec City Quebec Canada G1R 2J6
    9 Saskatchewan Cancer Agency Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • McMaster University
    • Cell Therapy Transplant Canada
    • Sanofi
    • Ozmosis Research Inc.

    Investigators

    • Principal Investigator: Irwin R Walker, MBBS, McMaster University
    • Principal Investigator: Kristjan Paulson, MD, CancerCare Manitoba

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT04202835
    Other Study ID Numbers:
    • CTTC1901
    • OZM-099
    First Posted:
    Dec 18, 2019
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by McMaster University
    post transplant cyclophosphamide
    anti-thymocyte globulin
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Graft vs Host Disease
    Cyclophosphamide
    Thymoglobulin
    Antilymphocyte Serum

    Study Results

    No Results Posted as of Aug 31, 2021