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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01394666
First received: July 8, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: At 3 months post treatment change ] [ Designated as safety issue: No ]
  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: At 6 months post treatment change ] [ Designated as safety issue: No ]
  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: At 12 months post treatment change ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 3 months after start of treatment ] [ Designated as safety issue: No ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 6 months after start of treatment ] [ Designated as safety issue: No ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 12 months after start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CP-CML patients who have failed Imatinib 400 mg daily

Detailed Description:

Time Perspective: Retrospective and Prospective

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic, academic and community oncology centers

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394666

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01394666     History of Changes
Other Study ID Numbers: CA180-240
Study First Received: July 8, 2011
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014