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SIMPLICITY

Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Recruitment period: 
1 May 2012 to 31 October 2018
Trial period: 
1 December 2013 to 1 January 2019
Clinical Trial reference link: 
NCT01244750

Treatments:

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

Collaborators

  • ICON Clinical Research

Primary Outcome Measures

  • The rate of Complete Cytogenetic Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The duration of initial TKI treatment [ Time Frame: 5-years from study index date ] [ Designated as safety issue: No ]
  • Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

The rate of discontinuation and treatment changes after initial TKI treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)