Back to resultsIdelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Primary Purpose
Follicular Lymphoma, Small Lymphocytic Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Idelalisib
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Cancer, Indolent Non-Hodgkin Lymphoma, FL, SLL
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed diagnosis of B-cell lymphoma
- No previous systemic treatment for lymphoma
- Subject demonstrates need for treatment for lymphoma
- Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
- Adequate performance status
- Required baseline laboratory data within protocol-specified parameters
Key Exclusion Criteria:
- Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- Ongoing inflammatory bowel disease
- Known human immunodeficiency virus (HIV) infection
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Pacific Shores Medical Group
- Florida Cancer Specialists
- St. Agnes Hospital
- Prarie Lakes Health Care Systems, Inc.
- Tennessee Oncology, PLLC
- Northwest Medical Specialties, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Idelalisib + rituximab
Arm Description
Idelalisib + rituximab for up to 104 weeks
Outcomes
Primary Outcome Measures
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Secondary Outcome Measures
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.
Idelalisib Trough and Peak Plasma Concentrations
Time to Response
Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
Overall Survival
Overall survival was defined as the interval from enrollment to death from any cause.
Changes in Health-Related Quality of Life
Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02258529
Brief Title
Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Official Title
A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
April 12, 2016 (Actual)
Study Completion Date
May 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma, Small Lymphocytic Lymphoma
Keywords
Cancer, Indolent Non-Hodgkin Lymphoma, FL, SLL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idelalisib + rituximab
Arm Type
Experimental
Arm Description
Idelalisib + rituximab for up to 104 weeks
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig®, GS-1101
Intervention Description
150 tablets administered orally twice daily
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®, MabThera®
Intervention Description
375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Secondary Outcome Measure Information:
Title
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Time Frame
Up to 24 weeks plus 30 days
Title
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Description
The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.
Time Frame
Up to 24 weeks plus 30 days
Title
Idelalisib Trough and Peak Plasma Concentrations
Time Frame
Predose and 1.5 hour postdose at Weeks 2, 4, and 12
Title
Time to Response
Description
Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
Title
Duration of Response
Description
Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
Title
Progression-Free Survival
Description
Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
Title
Overall Survival
Description
Overall survival was defined as the interval from enrollment to death from any cause.
Title
Changes in Health-Related Quality of Life
Description
Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of B-cell lymphoma
No previous systemic treatment for lymphoma
Subject demonstrates need for treatment for lymphoma
Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
Adequate performance status
Required baseline laboratory data within protocol-specified parameters
Key Exclusion Criteria:
Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
Ongoing inflammatory bowel disease
Known human immunodeficiency virus (HIV) infection
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Prarie Lakes Health Care Systems, Inc.
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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
Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
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