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

Completed · Phase 1/Phase 2

Conditions studied: Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma

In brief

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.

Key facts

Study ID

NCT01306643

Run by

Gilead Sciences

People needed

18

Starts

2011-02-01

Expected to finish

2015-08-01

Last updated by the study team

2018-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously treated relapsed or refractory B-cell iNHL
• Provide written informed consent

You may not qualify if…

• Pregnant or nursing
• Active, serious infection requiring systemic therapy
• Positive test for HIV antibodies
• Active hepatitis B or C viral infection

Where it is running

• Stanford Cancer Center — Palo Alto, California, United States
• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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