Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

Sponsor
SecuraBio
Study ID
NCT02204982
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Duvelisib — DRUG
    PI3K Inhibitor
  • Placebo — DRUG
    Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
  • Rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Sep 2023
Primary completion
Dec 31, 2016
Completion
Mar 31, 2017

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Duvelisib + Rituximab
    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.
  • Placebo Comparator: Placebo + Rituximab
    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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Until disease progression, for up to 5 years from randomization ]

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