Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
18 Years
N/A
Both
Leukemia, Myeloid, Chronic-Phase (CML-CP)
Trial Information
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
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.
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
Outcome Description:
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.
Outcome Time Frame:
CCyR at 6 month of 2GTKI treatment
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
CCTIRS: Advisory Council on Medical research data processing
Study ID:
CA180-291
NCT ID:
NCT01188278
Start Date:
July 2010
Completion Date:
December 2012
Related Keywords:
- Leukemia, Myeloid, Chronic-Phase (CML-CP)
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
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