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Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

NCT02605694 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-03-17

No results posted yet for this study

Summary

Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with relapsed/refractory FL

Conditions

Interventions

DRUG

Duvelisib

25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity

DRUG

Rituximab

375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).

DRUG

R-CHOP

IV infusion on Day 1 of Cycles 1-6 (21-day cycles) * Cyclophosphamide (750 mg/m2) * Doxorubicin hydrochloride (50 mg/m2) * Vincristine sulfate (1.4 mg/m2) (2 mg maximum) * Rituximab (375 mg/m2)

DRUG

Prednisone

100 mg orally on Days 1-5 of Cycles 1-6 (21-day cycles)

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian, MD · Verastem, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

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 NCT02605694 on ClinicalTrials.gov