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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394666
First Posted: July 14, 2011
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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 ]
  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: Baseline ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 3 months after start of treatment ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 6 months after start of treatment ]
  • Best response rates achieved by patients if no CCyR [ Time Frame: 12 months after start of treatment ]

Enrollment: 150
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394666


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01394666     History of Changes
Other Study ID Numbers: CA180-240
First Submitted: July 8, 2011
First Posted: July 14, 2011
Last Update Posted: July 11, 2016
Last Verified: July 2016

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