NCT01306643

Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.

Conditions

• Indolent Non-Hodgkin's Lymphoma
• Follicular Lymphoma
• Small Lymphocytic Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Idelalisib	Tablet(s) administered orally twice daily

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-03-02
• Last updated: 2018-11-19
• Results posted: 2016-12-21

Locations

2 sites across 1 country: United States