Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey

NCT ID: NCT01188278

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).

Detailed Description

Historic cohort prolonged by a 12-month follow-up period.

Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.

Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.

The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.

Conditions

Leukemia, Myeloid, Chronic-Phase (CML-CP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients in CP-CML treated with 2G TKI

Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure

Imatinib

Intervention Type: DRUG

Drug being observed but not provided

Interventions

Imatinib

Drug being observed but not provided

Intervention Type: DRUG

Other Intervention Names

Dasatinib; Nilotinob

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with CP-CML. (ACA) are allowed
• Age >18 years old
• Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
• Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.

Exclusion Criteria

• Patients in (or with history of) accelerated or blastic phase CML
• Patients treated by allogeneic stem cell transplantation.
• Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
• Patients treated with 2G TKI for reasons other than imatinib failure.
• Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
• Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

http://www.bms.com/clinical_trials/Pages/home.aspx

BMS Clinical Trials Disclosure

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Other Identifiers

CA180-291

Identifier Type: -

Identifier Source: org_study_id