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.
Who can participate
Age range16 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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
What they're measuring
1
Registration of 80 patients within twenty four months
✕. 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)