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

Completed

• Conditions: Leukemia, Myeloid, Chronic-Phase (CML-CP)
• Interventions: Drug: Imatinib

• Registration Number: NCT01188278
• Lead Sponsor: Bristol-Myers Squibb

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-10
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)	CCyR at 6 month of 2GTKI treatment	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.

Secondary Outcome Measures

Name	Time	Method
Predictive value of Hammersmith score compared to other factors	From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death	imatinib treatment duration, mutations at time of failure, best response to imatinib, time between imatinib failure \& initiation of 2G TKI on the response to 2G TKI \& on the survival end points (Overall Survival (OS)\& Progression Free Survival (PFS)).
Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs	For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010)
Predictive value of Hammersmith score on Major Molecular Response (MMR)	MMR at 3 month of 2GTKI treatment	The purpose of this study is to determine predictive value of Hammersmith score on Major Molecular Response(MMR), as assessed by the following: * Distribution of patients according to Hammersmith score levels; * Characterization of association between Hammersmith score and occurrence of MMR; * Assessment of capacity of Hammersmith score to predict MMR, using diagnostic test assessment methods.; This score is measured at the time of imatinib failure.
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)	From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI	When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009