Conditions: Chronic Lymphocytic Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).

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 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.

Detailed description:

Arms:
arm 1: Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. Following 4 weeks of treatment, safety data will be reviewed by an independent data monitoring committee (DMC). If acceptable tolerability is observed, the randomized portion of the study will begin. arm 2: Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. arm 3: Participants will receive obinutuzumab over 21 weeks and chlorambucil over 23 weeks.

Interventions: intervention 1: Idelalisib intervention 2: Chlorambucil intervention 3: Obinutuzumab
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: 2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses intervention 3: 1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks

Protocol document: