A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and 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 Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/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.
Halifax, Nova Scotia B3H 1V7, Canada
Ostrava - Poruba, Severomoravsky KRAJ 708 52, Czechia
Strasbourg, Alsace 67098, France
Villingen-Schwenningen, Baden-Wurttemberg 78054, Germany
Lódz, 93-510, Poland
Lublin, 20-081, Poland
Olsztyn, 10-228, Poland
Saint Petersburg, 191024, Russia
Saint Petersburg, 197341, Russia
Volgograd, 400138, Russia
Dorset, England BH7 7DW, United Kingdom
London, England NW1 2PG, United Kingdom