Extrait

• To evaluate the effect idelalisib (formerly GS-1101) on the onset, magnitude, and duration of tumor control • To compare tumor control in subjects receiving rituximab alone in Study GS-US-312-0116 to that observed in the same subjects when receiving the standard dose of idelalisib alone in Study GS-US-312-0117 • To assess the effect of idelalisib on measures of subject well-being, including overall survival (OS), health related quality of life (HRQL), and performance status • To assess the effects of idelalisib on disease associated biomarkers and to evaluate potential mechanisms of resistance to idelalisib • To characterize exposure to idelalisib as determined by treatment administration and evaluation of idelalisib plasma concentrations over time • To describe the safety profile observed with idelalisib • To estimate health resource utilization associated with administration of idelalisib

Critère d'inclusion

• Chronic lymphocytic leukemia (CLL)

Liens

• euctr
• ictrp
• euctr
• ictrp
• ictrp
• euctr