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

NCT02204982 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-09-28

Study results available
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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.

Conditions

Interventions

DRUG

Duvelisib

PI3K Inhibitor

DRUG

Placebo

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

DRUG

Rituximab

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.

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
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • Australia
  • France
  • Italy
  • Poland

Study Locations

More Related Trials

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 NCT02204982 on ClinicalTrials.gov