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

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ClinicalTrials.gov Identifier: NCT01394666
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease
Chronic Myeloid Leukemia

Detailed Description:
Time Perspective: Retrospective and Prospective

Study Type : Observational
Actual Enrollment : 150 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


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



Primary Outcome Measures :
  1. Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: At 3 months post treatment change ]
  2. Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily [ Time Frame: At 6 months post treatment change ]
  3. 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 :
  1. Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily [ Time Frame: Baseline ]
  2. 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. 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 ]
  4. 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 ]
  5. Best response rates achieved by patients if no CCyR [ Time Frame: Baseline ]
  6. Best response rates achieved by patients if no CCyR [ Time Frame: 3 months after start of treatment ]
  7. Best response rates achieved by patients if no CCyR [ Time Frame: 6 months after start of treatment ]
  8. Best response rates achieved by patients if no CCyR [ Time Frame: 12 months after start of treatment ]


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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.

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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01394666     History of Changes
Other Study ID Numbers: CA180-240
First Posted: July 14, 2011    Key Record Dates
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