Conditions: Chronic Lymphocytic Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 311
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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 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 idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. arm 2: Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Interventions: intervention 1: Idelalisib intervention 2: Bendamustine intervention 3: Rituximab intervention 4: Placebo
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area. intervention 3: Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions intervention 4: Placebo to match idelalisib administered orally twice daily

Protocol document: