NCT01882803

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma \[FL\], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

Detailed description

This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT. Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles. After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response \[CR\] or partial response \[PR\]) or stable disease according to the International Working Group criteria by the end of Cycle 13.

Conditions

• Indolent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Phosphoinositide-3-kinase (PI3K) inhibitor

Timeline

• Start date: 2013-06-17
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2013-06-20
• Last updated: 2023-09-07
• Results posted: 2018-11-20

Locations

69 sites across 12 countries: United States, Belarus, Belgium, Bulgaria, Canada, Czechia, France, Georgia, Hungary, Italy, Spain, United Kingdom