Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02576275

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)

A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination With Rituximab and Bendamustine vs Placebo Administered in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma

Status
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (actual)
Sponsor
SecuraBio · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

Study IPI-145-22 is an international, multicenter, randomized, double-blind, placebo-controlled, two-arm Phase 3 study designed to evaluate efficacy and safety of DBR vs PBR in subjects with previously-treated iNHL (including follicular lymphoma \[FL\], small lymphocytic lymphoma \[SLL\] and marginal zone lymphoma \[MZL\]). Approximately 600 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 on Day 1 of Cycles 1-6 and 90 mg/m2 of bendamustine given on Day 1 and Day 2 of Cycles 1-6. Subjects will receive duvelisib until disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGDuvelisibDuvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
DRUGPlaceboMatching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles
DRUGRituximabIV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.
DRUGBendamustineIV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.

Timeline

Start date
2015-12-01
Primary completion
2016-11-01
Completion
2016-11-01
First posted
2015-10-15
Last updated
2021-03-17

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02576275. Inclusion in this directory is not an endorsement.