Dose Optimization Study of Idelalisib in Follicular Lymphoma

Official Title

Dose Optimization Study of Idelalisib in Follicular Lymphoma

Summary:

This study will optimize the safety and efficacy of chronic administration of idelalisib in participants with follicular lymphoma (FL) and evaluate the overall safety profile of idelalisib and the overall response rate (ORR) by Week 24.

Trial Description

Primary Outcome:

• Overall safety profile of idelalisib, including the incidence of adverse events and clinically significant laboratory abnormalities
• Overall response rate (ORR) by Week 24

• Time to onset of adverse events (AEs) of interest
• Rate of AE of interest
• Rate of drug interruptions for the number of participants with AE of interest
• Progression-free survival (PFS)
• Duration of response (DOR)
• Overall survival (OS)
• Idelalisib trough (pre-dose) and peak (1.5-hour samples) plasma concentrations

View this trial on ClinicalTrials.gov