Conditions: Follicular Lymphoma
Keywords: Phase 3, Follicular Lymphoma, FL, PI3K
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 13
Healthy volunteers: no

Brief summary:
A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.

Detailed description:
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

Arms:
arm 1: Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.

Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg. arm 2: Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.

Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.

Interventions: intervention 1: Duvelisib intervention 2: Placebo intervention 3: Rituximab
Intervention descriptions: intervention 1: PI3K Inhibitor intervention 2: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles. intervention 3: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

Protocol document: