A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA)

Part of paid clinical trials in Plainville, Connecticut.

Sponsor
SecuraBio
Study ID
NCT02576275
Phase
PHASE3
Status
Withdrawn

Conditions

  • Follicular Lymphoma
  • Indolent Non-Hodgkin's Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Duvelisib — DRUG
    Duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
  • Placebo — DRUG
    Matching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles
  • Rituximab — DRUG
    IV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.
  • Bendamustine — DRUG
    IV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.

Study Details

This study will evaluate the efficacy and safety of duvelisib in combination with bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2021
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

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

Arms

  • Experimental: Duvelisib + Rituximab + Bendamustine
    Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Bendamustine is administered as an intravenous (IV) infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
  • Placebo Comparator: Placebo + Rituximab + Bendamustine
    Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules of duvelisib. Bendamustine is administered as an IV infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an 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: From date of enrollment until the date of first documentation of progression or date of death from any cause, whatever came first, assessed up to 78 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
-PlainvilleConnecticut06062-
-PlantationFlorida33322-
-ThomasvilleGeorgia31792-
-East SetauketNew York11733-3456-
-CookevilleTennessee38501-
-KnoxvilleTennessee37909-
-SpokaneWashington99208-

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