Conditions: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Keywords: Chronic Lymphocytic Leukemia CLL
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

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 rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).

Interventions: intervention 1: Idelalisib intervention 2: Rituximab
Intervention descriptions: intervention 1: 150 mg tablets administered orally twice daily intervention 2: 375 mg/m\^2 administered intravenously once weekly x 8 weeks

Protocol document: