BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.
Study Type
OBSERVATIONAL
Enrollment
317
Standford Cancer Center
Palo Alto, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Medizinische Universitat Wien
Vienna, Austria
Universitatmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Comparative evaluation of overall survival (OS) between patients receiving best available therapy versus avapritinib in BU-285-2101 and BLU-285-2202
Overall Survival defined as time from initiation of systemic treatment to death from any cause
Time frame: up to 12 years
Comparative evaluation between patients receiving best available therapy versus avapritinib of duration of treatment (DOT)
DOT, defined as the duration from initiation of line of systemic treatment to discontinuation of same line of treatment for any reason and;
Time frame: Up to 12 years
Comparative evaluation between patients receiving best available therapy versus avapritinib and time to next treatment line (TtNTL)
TtNTL, defined as the time from initiation of the line of systemic treatment to the initiation of the next line of treatment
Time frame: Up to 12 years
Comparative evaluation of change in serum tryptase concentration in patients receiving best available therapy versus avapritinib
Change in serum tryptase concentration, defined as change in serum tryptase from baseline, for each line of therapy
Time frame: Up to 12 years
To characterize the safety profile and conduct comparative evaluation of safety between patients receiving best available therapy vs. avapritinib
AEs that result in treatment modification or discontinuation, hospitalization, or death according to evaluation of responsible physician
Time frame: Up to 12 years
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Hospital Virgen del Valle
Toledo, Spain
Guy's and St. Thomas' NHS Foundation Trust
London, England, United Kingdom