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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Leukemia, Myeloid, Chronic-Phase (CML-CP)

Treatments: Drug: Imatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT01188278

CA180-291

Details and patient eligibility

About

The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

173 participants in 1 patient group

Patients in CP-CML treated with 2G TKI

Description:

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

Treatment:

Drug: Imatinib