NCT02605694

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

A Phase 2, Randomized Study of Duvelisib Administered in Combination With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a phase 2, randomized, two-arm, open-label study designed to evaluate the efficacy and safety of Duvelisib Administered in Combination with Rituximab vs R-CHOP in Subjects with Relapsed/Refractory Follicular Lymphoma.

Conditions

• Lymphoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-11-16
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States