Conditions: Indolent Non-Hodgkin's Lymphomas
Keywords: iNHL indolent NHL follicular lymphoma CAL-101 Rituximab Small lymphocytic lymphoma lymphoplasmacytoid lymphoma Waldenstrom macroglobulinemia LPL WM Marginal zone lymphoma MZL SLL FL GS-1101 idelalisib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 295
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants will receive rituximab + idelalisib. arm 2: Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.

Interventions: intervention 1: Placebo intervention 2: Rituximab intervention 3: Idelalisib
Intervention descriptions: intervention 1: Tablets administered orally twice daily intervention 2: 375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions) intervention 3: 150 mg tablets administered orally twice daily

Protocol document: