Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
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
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.
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.
Observational Model: Cohort, Time Perspective: Prospective
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following: Distribution of patients according to Hammersmith score levels Characterization of association between Hammersmith score and occurrence of CCyR Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods. This score is measured at the time of imatinib failure.
CCyR at 6 month of 2GTKI treatment
CCTIRS: Advisory Council on Medical research data processing