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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04202835
Recruitment Status : Not yet recruiting
First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Cell Therapy Transplant Canada
Sanofi
Ozmosis Research Inc.
Information provided by (Responsible Party):
McMaster University

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
Acute Leukemia Myelodysplasia Chronic Graft-versus-host-disease Drug: Cyclophosphamide Drug: Anti-Thymocyte globulin (rabbit) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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)
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


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 Name: 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 Name: Thymoglobulin




Primary Outcome Measures :
  1. Registration of 80 patients within twenty four months [ Time Frame: 24 months ]
    Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)


Secondary Outcome Measures :
  1. CRFS [ Time Frame: 27 months ]
    Chronic graft versus host disease free- and relapse-free survival (CRFS)

  2. GRFS [ Time Frame: 27 months ]
    Graft versus host disease-, and relapse-, free survival (GRFS)

  3. Survival [ Time Frame: 27 months ]
    Survival (dead/alive) at 100 days for each patient

  4. Complete data collection [ Time Frame: 27 months ]
    The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection

  5. Cost of study [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participant is aged between 16 and 70
  2. The participant has either

    1. Acute myeloid leukemia in remission, or
    2. Myelodysplastic syndrome
  3. The participant will receive a Hematopoietic Progenitor Cell graft obtained by apheresis ("HPC, Apheresis")
  4. The participant has a related or unrelated donor, who is either fully Major Histocompatibility Complex (MHC)-matched with the recipient at Human Leukocyte Antigen (HLA)-A, B, C and DRB1 or is 1-antigen or 1-allele mismatched at these loci.
  5. The participant meets the transplant centre's criteria for transplantation, using either myeloablative or non-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.

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 transplant
  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 transplant2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202835


Contacts
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Contact: Sarah Kleiboer 1 416 634 8322 sarah.kleiboer@ozmosisresearch.com

Sponsors and Collaborators
McMaster University
Cell Therapy Transplant Canada
Sanofi
Ozmosis Research Inc.
Investigators
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Principal Investigator: Irwin R Walker, MBBS McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04202835    
Other Study ID Numbers: CTTC1901
OZM-099 ( Other Identifier: Ozmosis Research Inc )
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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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:
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Preleukemia
Myelodysplastic Syndromes
Graft vs Host Disease
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Cyclophosphamide
Thymoglobulin
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists