NCT01394666

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

July 8, 2011

Last Update Submit

July 8, 2016

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily

    At 3 months post treatment change

  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily

    At 6 months post treatment change

  • Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily

    At 12 months post treatment change

Secondary Outcomes (8)

  • Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily

    Baseline

  • 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

  • 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

  • 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

  • Best response rates achieved by patients if no CCyR

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

CP-CML patients who have failed Imatinib 400 mg daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic, academic and community oncology centers

You may qualify if:

  • Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 14, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 11, 2016

Record last verified: 2016-07