Back to resultsSafety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
Primary Purpose
Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Idelalisib
Sponsored by
About this trial
This is an interventional treatment trial for Indolent Non-Hodgkin's Lymphoma focused on measuring Indolent Non-Hodgkin's Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL)
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
Sites / Locations
- Stanford Cancer Center
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Idelalisib
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01306643
Brief Title
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma
Keywords
Indolent Non-Hodgkin's Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idelalisib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
GS-1101, CAL-101, Zydelig®
Intervention Description
Tablet(s) administered orally twice daily
Primary Outcome Measure Information:
Title
Overall Safety of Idelalisib
Description
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).
Time Frame
30 days post last study treatment (up to 12 months)
Title
Clinical Response: Overall Response Rate
Description
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.
Time Frame
Up to twelve 28-day cycles (maximum of 12 months)
Secondary Outcome Measure Information:
Title
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)
Title
Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Time Frame
Up to twelve 28-day cycles (maximum of 12 months)
Title
Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Time Frame
Up to twelve 28-day cycles (maximum of 12 months)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-5548
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Learn more about this trial
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
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