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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)

NCT02576275 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-03-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Duvelisib

Duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles

DRUG

Placebo

Matching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles

DRUG

Rituximab

IV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.

DRUG

Bendamustine

IV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian, MD · Verastem, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576275 on ClinicalTrials.gov