Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Chronic Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01244750

CA180-330

Details and patient eligibility

About

The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

Full description

Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)

Enrollment: 1,494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below

• 18 years or older at time of of CP-CML diagnosis

  a) Imatinib Cohorts

• Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients

• Patients who started their first-line Imatinib treatment on or after October 1, 2010

  b) Dasatinib Cohort

• Patients who started their first-line Dasatinib treatment after the drug was approved in this indication

  c) Nilotinib Cohort

• Patients who started their first-line Nilotinib treatment after the drug was approved in this indication

• Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)

• Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)

Exclusion criteria

• Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded

Discontinuation Criteria:

• Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial

Trial design

1,494 participants in 4 patient groups

First line TKI treatment: Imatinib

Description:

Diagnosed CML patients who receive first line TKI treatment: Imatinib

First line TKI treatment: Nilotinib

Description:

Diagnosed CML patients who receive first line TKI treatment: Nilotinib

First line TKI treatment: Dasatinib

Description:

Diagnosed CML patients who receive first line TKI treatment: Dasatinib

Imatinib treated patients

Description:

Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010