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

Phase 2

Completed

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT00219752
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Study Timeline

• Study Start: 2002-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Last Update Submitted: 2005-12-21
• Last Update Posted: 2005-12-22
• Study Completion: 2007-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• CML Ph+ (assessed by cytogenetic or FISH)
• Chronic phase with less than 5% bone marrow blasts
• Diagnosis within 12 months
• Age ≥ 70 year at inclusion
• PS grade 0 to 2 (ECOG)
• Mini mental status more than 25
• Hydroxyurea optional before Imatinib
• Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.

Exclusion Criteria

• patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
• Mini mental status ≤ 25
• patients who are not able to adequately take the study drug
• Age less than 70 y
• accelerated or blastic phase
• previous therapy with imatinib or interferon
• HIV positivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tolerability
Quality of life

Secondary Outcome Measures

Name	Time	Method
. 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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Poitiers, France