Trial | NCT04202835  Report issue

Title

ATG Plus PTCy vs ATG for CGVHD Prophylaxis
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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    80
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.
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 Started
Oct 13
2020
Primary Completion
Oct 13
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Mar 15
2023

Drug Cyclophosphamide

Post Transplant Cyclophosphamide

Drug Anti-Thymocyte globulin (rabbit)

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

  • Other names: Thymoglobulin

ATG/PTCy Experimental

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.

ATG Active Comparator

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).

Criteria 

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)
No Results Posted