Status:
COMPLETED
Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Myeloid, Chronic-Phase (CML-CP)
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- Patients with Additional Chromosomal Anomalies (ACA) are accepted to be in CP. Patients enrolled in open-label clinical trials or other observational trials are also allowed (unless explicitly prohibited by the trial).
- This trial does not prohibit participation in other observational trials.
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01188278
Start Date
July 1 2010
End Date
January 1 2013
Last Update
September 30 2016
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