Leukemia, Myeloid, Chronic-Phase (CML-CP) Clinical Trial
Official title:
Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
| Status | Completed |
| Enrollment | 173 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Predictive value of Hammersmith score on Major Molecular Response (MMR) | 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. |
MMR at 3 month of 2GTKI treatment | Yes |
| Secondary | 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 | Yes | |
| Secondary | Predictive value of Hammersmith score compared to other factors | 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)). | From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death | Yes |
| Secondary | 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 | Yes | |
| Secondary | 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) | Yes |