NCT01282424

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

Conditions

• Follicular Lymphoma
• Small Lymphocytic Lymphoma
• Lymphoplasmacytic Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Idelalisib	Idelalisib 150 mg tablet administered orally twice daily

Timeline

• Start date: 2011-03-18
• Primary completion: 2018-05-02
• Completion: 2018-05-16
• First posted: 2011-01-25
• Last updated: 2019-07-11
• Results posted: 2014-09-04

Locations

41 sites across 6 countries: United States, France, Germany, Italy, Poland, United Kingdom

Regulatory

• FDA-regulated drug study