NCT04707079

A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma

A Phase 2, Single Arm, Open Label, Multi-center Clinical Study of Dual PI3K-δ,γ Inhibitor Duvelisib in Patients With Relapsed/Refractory Follicular Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (FL) that is relapsed or refractory to either chemotherapy or radioimmunotherapy (RIT).

Detailed description

This is an open-label, single arm, multi-center clinical trial to evaluate the efficacy and safety of duvelisib administered to subjects who have been diagnosed with follicular lymphoma that is relapsed or refractory to either chemotherapy or RIT. Subjects (n=57) will receive 25 mg duvelisib twice daily (BID) over the course of 28-day treatment cycles for up to 12 cycles. After completing 12 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 12 cycles, subjects must have evidence of response (CR, PR or SD) by the end of Cycle 12.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Eligible subjects will be given duvelisib orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.

Timeline

• Start date: 2019-12-18
• Primary completion: 2021-10-31
• Completion: 2022-03-31
• First posted: 2021-01-13
• Last updated: 2021-01-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study