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

July 8, 2016 updated by: Bristol-Myers Squibb

Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Time Perspective: Retrospective and Prospective

Study Type

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic, academic and community oncology centers

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CP-CML patients who have failed Imatinib 400 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time Frame: At 3 months post treatment change
At 3 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time Frame: At 6 months post treatment change
At 6 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time Frame: At 12 months post treatment change
At 12 months post treatment change

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time Frame: Baseline
Baseline
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time Frame: 3 months after start of treatment
3 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time Frame: 6 months after start of treatment
6 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time Frame: 12 months after start of treatment
12 months after start of treatment
Best response rates achieved by patients if no CCyR
Time Frame: Baseline
Baseline
Best response rates achieved by patients if no CCyR
Time Frame: 3 months after start of treatment
3 months after start of treatment
Best response rates achieved by patients if no CCyR
Time Frame: 6 months after start of treatment
6 months after start of treatment
Best response rates achieved by patients if no CCyR
Time Frame: 12 months after start of treatment
12 months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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