Skip to main content
OpenTrials
Completed

NCT Number: NCT01394666

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Time Perspective: Retrospective and Prospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2011
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.