Conditions: Indolent Non-Hodgkin's Lymphomas
Keywords: iNHL indolent NHL follicular lymphoma CAL-101 rituximab bendamustine small lymphocytic lymphoma lymphoplasmacytoid lymphoma Waldenstrom macroglobulinemia LPL WM Marginal zone lymphoma MZL SLL FL GS-1101 PI3K inhibitor idelalisib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 475
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants will receive rituximab + bendamustine + idelalisib. arm 2: Participants will receive rituximab + bendamustine + placebo.

Interventions: intervention 1: Idelalisib intervention 2: Rituximab intervention 3: Bendamustine intervention 4: Placebo
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: 375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions) intervention 3: 90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated) intervention 4: Tablet administered orally twice daily

Protocol document: