Clinical trial NCT01188278: Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey
Official title: Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid, Chronic-Phase (CML-CP)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematology centers (hospitals) which have necessary historical data available

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
timeFrame: CCyR at 6 month of 2GTKI treatment
Secondary outcomes:
measure: Predictive value of Hammersmith score on Major Molecular Response (MMR)
timeFrame: MMR at 3 month of 2GTKI treatment
measure: Predictive factors of Overall survival (including Hammersmith score, MMR at 3 months and CCyR at 6 months of 2G TKI treatment together with patients, disease and treatment characteristics)
timeFrame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
measure: Predictive value of Hammersmith score compared to other factors
timeFrame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
measure: Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI
timeFrame: When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009
measure: Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs
timeFrame: For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010)
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: