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

Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306643
• Other study ID #: 101-10
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Indolent Non-Hodgkin's Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Idelalisib
Tablet(s) administered orally twice daily

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York
United States	Stanford Cancer Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Safety of Idelalisib	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).	30 days post last study treatment (up to 12 months)
Primary	Clinical Response: Overall Response Rate	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.	Up to twelve 28-day cycles (maximum of 12 months)
Secondary	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)
Secondary	Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells		Up to twelve 28-day cycles (maximum of 12 months)
Secondary	Changes in Concentration of Peripheral Blood Chemokines and Cytokines		Up to twelve 28-day cycles (maximum of 12 months)
Secondary	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)