NCT00219752

Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Imatinib mesylate 400 mg

Timeline

• Start date: 2002-05-01
• Completion: 2007-05-01
• First posted: 2005-09-22
• Last updated: 2005-12-22

Locations

1 site across 1 country: France