Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
|ClinicalTrials.gov Identifier: NCT01306643|
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Indolent Non-Hodgkin's Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma||Drug: Idelalisib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Tablet(s) administered orally twice daily
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|