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

Phase 1

Completed

• Conditions: Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Follicular Lymphoma; Indolent Non-Hodgkin's Lymphoma
• Interventions: Drug: Idelalisib

• Registration Number: NCT01306643
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-08-23
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-27
• Results First Posted: 2016-12-21
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idelalisib	Idelalisib	-

Primary Outcome Measures

Name	Time	Method
Overall Safety of Idelalisib	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	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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States