Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
NCT ID: NCT02258529
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2015-09-14
2016-05-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idelalisib + rituximab
Idelalisib + rituximab for up to 104 weeks
Idelalisib
150 tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Interventions
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Idelalisib
150 tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Pacific Shores Medical Group
Long Beach, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Prarie Lakes Health Care Systems, Inc.
Watertown, South Dakota, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Countries
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Other Identifiers
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GS-US-313-1414
Identifier Type: -
Identifier Source: org_study_id
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