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

Not Recruiting

Trial ID: NCT01306643

Purpose

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.

Official Title

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

Stanford Investigator(s)

Ronald Levy
Ronald Levy

Robert K. and Helen K. Summy Professor in the School of Medicine

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Intervention(s):

drug: Idelalisib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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