- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394666
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
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.
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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