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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
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