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
Overview
- Phase
- Phase 1
- Intervention
- Idelalisib
- Conditions
- Indolent Non-Hodgkin's Lymphoma
- Sponsor
- Gilead Sciences
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Overall Safety of Idelalisib
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Idelalisib
Intervention: Idelalisib
Outcomes
Primary Outcomes
Overall Safety of Idelalisib
Time Frame: 30 days post last study treatment (up to 12 months)
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Clinical Response: Overall Response Rate
Time Frame: Up to twelve 28-day cycles (maximum of 12 months)
Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12. Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment. * CR was defined as the disappearance of all evidence of disease. * PR was defined the regression of measurable disease and no new sites.
Secondary Outcomes
- Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast(Up to twelve 28-day cycles (maximum of 12 months))
- Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells(Up to twelve 28-day cycles (maximum of 12 months))
- Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells(Up to twelve 28-day cycles (maximum of 12 months))
- Changes in Concentration of Peripheral Blood Chemokines and Cytokines(Up to twelve 28-day cycles (maximum of 12 months))