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The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in CP-CML treated with 2G TKI | Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | Drug being observed but not provided |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
This score is measured at the time of imatinib failure. | CCyR at 6 month of 2GTKI treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
This score is measured at the time of imatinib failure. |
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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:
Exclusion Criteria:
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Hematology centers (hospitals) which have necessary historical data available
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| MMR at 3 month of 2GTKI treatment |
| 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 |
| 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 |
| 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 |
| 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) |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |