Conditions: Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)
Keywords: CLL SLL GS-1101 CAL-101 Phosphatidylinositol 3-kinase (PI3K) Rituximab Rituxan
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 105
Healthy volunteers: no

Brief summary:
This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL.

This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.

Detailed description:

Arms:
arm 1: This arm consists of 2 cohorts. Participants in Cohort 1 will receive idelalisib for up to twelve 28-day cycles (or development of unacceptable toxicity) plus rituximab (8 doses through the end of Cycle 2). Upon completion of twelve 28-cycles, participants are eligible to remain on idelalisib in a continuation protocol. Participants in Cohort 2 will receive idelalisib until disease progression or development of unacceptable toxicity.

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

Protocol document: