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 Phase I-II
Type étude Traitement
Médicament Bortezomib et vorinostat
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL DE MONTREAL POUR ENFANTS
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dre Catherine Vézina
Coordonnateur(trice) Dominique Lafrenière
 514-412-4400 poste 24771
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.