Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)

Completed

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT01394666
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.

Detailed Description

Time Perspective: Retrospective and Prospective

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily	At 12 months post treatment change

Secondary Outcome Measures

Name	Time	Method
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily	12 months after start of treatment
Best response rates achieved by patients if no CCyR	12 months after start of treatment