Groupe d'Etude en Oncologie du Quebec

Title	Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Protocole ID	TINI
ClinicalTrials.gov ID	NCT02553460
Cancer Type(s)	Pediatric
Phase	Phase I-II
Stage
Study Type	Treatment
Drug	Bortezomib et vorinostat
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL CHUL ET CENTRE MERE-ENFANT SOLEIL 2705 boulevard Laurier, Québec, QC, G1V 4G2
City	Québec
Principal Investigator	Dr. Bruno Michon
Coordinator	Marie-Christine Gagnon 418-525-4444 poste 40196
Status	Recruiting
Activation Date
Eligibility Criteria	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.
Exclusion Criteria	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