Clinical Trial reference link:
NCT01244750You are here
SIMPLICITY
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Recruitment period:
1 May 2012 to 31 October 2018Trial period:
1 December 2013 to 1 January 2019This 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)