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

Indolent Non-Hodgkin Lymphoma Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Indolent Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT01882803
• Study type: Interventional
• Source: SecuraBio
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2013
• Completion date: November 18, 2020