Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
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|ClinicalTrials.gov Identifier: NCT00219752|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 22, 2005
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Imatinib mesylate 400 mg||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2002|
|Study Completion Date :||May 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219752
|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)|