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

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306643

101-10

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Idelalisib

Experimental group

Treatment:

Drug: Idelalisib