Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
NCT ID: NCT01732913
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
295 participants
INTERVENTIONAL
2013-01-16
2016-05-18
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 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
Rituximab
375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Idelalisib
150 mg tablets administered orally twice daily
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Placebo
Tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Idelalisib
150 mg tablets administered orally twice daily
Interventions
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Placebo
Tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Idelalisib
150 mg tablets administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Follicular lymphoma (FL) Grade 1, 2, or 3a
2. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis
3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
* Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
* Received previous treatment with rituximab that was not effective.
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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Clearview Cancer Institute
Huntsville, Alabama, United States
Ironwood Cancer and Research Center
Chandler, Arizona, United States
City of Hope Cancer Center
Duarte, California, United States
Saint Jude Heritage Healthcare
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA Medical Center
Los Angeles, California, United States
Cancer Care Associates
Redondo Beach, California, United States
Cancer Center of Santa Barbara
Santa Barbara, California, United States
Central Coast Medical Oncology Group
Santa Maria, California, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists and Research Institute
Fort Myers, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Wayne State University
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Texas Oncology, P.A.
Bedford, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Center for Cancer and Blood Disorders, PC
Fort Worth, Texas, United States
Shenandoah Oncology Associates, PC
Winchester, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Haematology and Oncology Clinics of Australia at Chermside
Milton, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Saint Vincent's Hospital
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Adelaide Cancer Centre
Kurralta Park, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Fakultní nemocnice Hradec Králové
Hradec Králové, , Czechia
University Hospital of Bordeaux
Pessac, Aquitaine, France
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire Brest
Brest, , France
Centre Hospitalier de Dunkerque
Dunkirk, , France
Centre Hospitalier de Versailles
Le Chesnay, , France
Centre Léon Bérard
Lyon, , France
Hôpital Hôtel-Dieu
Nantes, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
Poitiers, , France
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Dres. Söling Und Siehl
Kassel, Hesse, Germany
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
Debrecen, Hajdú-Bihar, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, Vas County, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Hadassah Medical Organization, Ein Kerem
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, , Italy
Centro di Riferimento Oncologico di Aviano
Pordenone, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Kyushu Cancer Center
Minamiku, Fukuoka, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
National Hospital Organization Kumamoto Medical Center
Chuo-ku, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn, , Poland
Centrum Onkologii i Hipertermii
Warsaw, , Poland
Hospital Geral de Santo António do Centro Hospitalar do Porto
Porto, , Portugal
Institutul Clinic Fundeni
Bucharest, , Romania
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, , Russia
Ryazan Regional Clinical Hospital
Ryazan, , Russia
Saint Petersburg I.P. Pavlov State Medical University
Saint Petersburg, , Russia
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
Singapore General Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Gleneagles Medical Centre
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Skånes Universitetssjukhus, Malmö
Malmo, , Sweden
Chang Gung Memorial Hospital (CGMH)
Kaohsiung City, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Barts and The London NHS Trust
London, England, United Kingdom
Mount Vernon Hospital
Middlesex, , United Kingdom
Sunderland Royal Infirmary
Sunderland, , United Kingdom
Countries
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Other Identifiers
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GS-US-313-0124
Identifier Type: -
Identifier Source: org_study_id
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