| TITRE |
Traitement de la leucémie aiguë lymphoblastique chez les enfants de moins d’un an
|
| PROTOCOLE ID |
TINI |
| CLINICAL TRIAL.gov ID |
NCT02553460 |
| TYPE(S) DE CANCER |
Pédiatrique divers |
| PHASE |
Phase I-II |
| TYPE D'ÉTUDE |
Traitement |
| INSTITUTION |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Bruno Michon
|
| COORDONATEUR(RICE) |
Marie-Christine Gagnon
418-525-4444 poste 40196
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
-
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.
|
| CRITÈRES D'EXCLUSION |
(EN)
-
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.
|
