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Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

18 Years
Open (Enrolling)
Chronic Myeloid Leukemia

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Trial Information

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

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)

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,

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

Type of Study:


Study Design:

Observational Model: Cohort

Outcome Measure:

The rate of Complete Cytogenetic Response

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

December 2017

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic Phase - Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



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