Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
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.
|Indolent Non-Hodgkin's Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma||Drug: Idelalisib||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
- Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
- Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
- Changes in Concentration of Peripheral Blood Chemokines and Cytokines [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
- Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
|Study Start Date:||February 2011|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Tablet(s) administered orally twice daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306643
|United States, California|
|Stanford Cancer Center|
|Palo Alto, California, United States, 94304-5548|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Director:||Gilead Study Director||Gilead Sciences|