Titre 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)
Protocole ID CTTC 1901
ClinicalTrials.gov ID NCT04202835
Type(s) de cancer Leucémie myéloïde aiguë (LMA)
Phase Phase II
Type étude Autre
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DE L'ENFANT-JESUS
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dre Geneviève Gallagher
Coordonnateur(trice) Philippe Nadeau
418-649-0252 poste 63501
Statut Actif en recrutement
Critètes d'éligibilité
  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 fully Major Histocompatibility Complex (MHC)-matched with the recipient at Human Leukocyte Antigen (HLA)-A, B, C and DRB1.
  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.
Critètes d'exclusion
  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 transplant.
  7. The participant has Mixed Phenotype Acute Leukemia.