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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394666
• Other study ID #: CA180-240
• Status: Completed
• Phase: N/A
• First received: July 8, 2011
• Last updated: July 8, 2016
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Time Perspective: Retrospective and Prospective

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily		At 3 months post treatment change	No
Primary	Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily		At 6 months post treatment change	No
Primary	Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily		At 12 months post treatment change	No
Secondary	Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily		Baseline	No
Secondary	Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily		3 months after start of treatment	No
Secondary	Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily		6 months after start of treatment	No
Secondary	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	No
Secondary	Best response rates achieved by patients if no CCyR		Baseline	No
Secondary	Best response rates achieved by patients if no CCyR		3 months after start of treatment	No
Secondary	Best response rates achieved by patients if no CCyR		6 months after start of treatment	No
Secondary	Best response rates achieved by patients if no CCyR		12 months after start of treatment	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
•   Investigator Inquiry form