| 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 63115
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- The participant is aged between 16 and 70
-
The participant has either
- Acute myeloid leukemia in remission, or
- Myelodysplastic syndrome
- The participant will receive a Hematopoietic Progenitor Cell graft obtained by apheresis ("HPC, Apheresis")
- 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.
- The participant meets the transplant centre's criteria for transplantation, using either myeloablative or non-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.
|
| Critètes d'exclusion |
- 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 transplant
- 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.
- The participant has Mixed Phenotype Acute Leukemia.
|
Groupe d'étude en oncologie du Québec