Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/21/2018 |
| Start Date: | February 2011 |
| End Date: | August 2015 |
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
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.
(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.
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
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