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

Trial ID or NCT#

NCT01306643

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Previously treated relapsed or refractory B-cell iNHL - Provide written informed consent
Exclusion Criteria:
  1. - Pregnant or nursing - Active, serious infection requiring systemic therapy - Positive test for HIV antibodies - Active hepatitis B or C viral infection

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061