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Sponsors and Collaborators: |
Poitiers University Hospital Novartis |
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Information provided by: | Poitiers University Hospital |
ClinicalTrials.gov Identifier: | NCT00219752 |
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.
Condition | Intervention | Phase |
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Chronic Myeloid Leukemia |
Drug: Imatinib mesylate 400 mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
University Hospital | |
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) |
Study ID Numbers: | 020948, CSTI571AFR04 |
Study First Received: | September 13, 2005 |
Last Updated: | December 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00219752 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
CML - ederly patients - Imatinib mesylate |
Imatinib Leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Chronic Myelogenous Leukemia Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |