Pédiatrique divers

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
TYPE D'ÉTUDE Traitement
INSTITUTION CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
3175 Chemin de la Côte Sainte-Catherine
(514) 345-4931
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Henrique Bittencourt
COORDONATEUR(RICE) Lynda Dufresne
lynda.dufresne@recherche-ste-justine.qc.ca
514-345-4931 poste 4969
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.