Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life
will be assessed Secondary objectives are : to evaluate the survival without progression,
the survival without event, the overall survival, the hematologic, cytogenetic and molecular
responses at various check points.
Duration of responses and failure to respond will be evaluated.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability
François GUILHOT, MD
Study Chair
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
020948
NCT00219752
May 2002
May 2007
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