A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Key Inclusion Criteria:
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Lille, Hauts-de-France 59037, France
Villingen-Schwenningen, Baden-Wurttemberg 78052, Germany
Isehara-shi, Kanagawa 259-1193, Japan
Chuo-ku, Kumamoto 860-0008, Japan
Chuo-ku, Tokyo 1040045, Japan
Koto-ku, Tokyo 135-8550, Japan
Minato-ku, Tokyo 1058470, Japan
Olsztyn, 10-228, Poland
Saint Petersburg, 197341, Russia