Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
The aim of this phase II trial is asses 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. Quality of life will be carefully assessed.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Quality of life
- . 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
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||May 2007|
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.
|Poitiers, France, 86021|
|Study Chair:||François GUILHOT, MD||Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE|
|Principal Investigator:||Philippe ROUSSELOT, MD||Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)|