Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Status:
Terminated
Trial end date:
2016-05-03
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the overall response rate (ORR) and
complete response (CR) rate to treatment with idelalisib in combination with rituximab in
previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma
(SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with
front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma
(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 those studies in agreement with
the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
All front-line studies of idelalisib, including this study, were also terminated.