| Titre |
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
|
| Protocole ID |
TINI |
| ClinicalTrials.gov ID |
NCT02553460 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
|
| Type étude |
Traitement |
| Médicament |
Bortezomib et vorinostat |
| Institution |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Henrique Bittencourt
|
| Coordonnateur(trice) |
Lynda Dufresne
514-345-4931 poste 4969
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
-
Patient is ≤ 365 days of age at the time of diagnosis.
-
Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid.
-
Limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
-
Written informed consent following Institutional Review Board, NCI, FDA, and Office for Human Research Protections (OHRP) Guidelines.
|
| Critètes d'exclusion |
-
Patients with prior therapy, other than therapy specified in the Inclusion Criteria.
-
Patients with mature B-cell ALL or acute myelogenous (AML).
-
Patients with Down syndrome.
-
Inability or unwillingness of legal guardian/representative to give written informed consent.
|
Groupe d'étude en oncologie du Québec