311
Participants
Start Date
February 5, 2014
Primary Completion Date
May 30, 2016
Study Completion Date
June 16, 2016
Idelalisib
150 mg tablet administered orally twice daily
Bendamustine
Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area.
Rituximab
Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions
Placebo
Placebo to match idelalisib administered orally twice daily
Semmelweis University, Budapest
National Institute of Oncology, Budapest
St Vincent's Hospital, Sydney, Darlinghurst
Z N A Stuivenberg, Antwerp
Jarrett Street Specialist Centre, North Gosford
Calvary Mater Newcastle, Waratah
Szent Borbála Hospital, Tatabánya
University Hospital Leuven, Leuven
Frankston Hospital, Frankston
Barwon Health, University Hospital Geelong, Geelong
University of Debrecen HSC Institute of internal Medicine, Department of Hematology, Debrecen
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital, Adelaide
Queen Elizabeth Hospital, Woodville South
Ashford Cancer Centre Research, Kurralta Park
Flinders Medical Centre, Department of Haematology, Level 6, Bedford Park
Pandy Kalman Hospital, Gyula
Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika, Szeged
Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,, Kaposvár
University Of Pecs, Medical School, Pécs
AZ Sint-Jan AV Brugge-Oostende, Bruges
Hospital de la Santa Creu i Sant Pau, Barcelona
ICO, Hospitalet de Llobregat, Barcelona
Klinicka bolnica Dubrava, Zagreb
Klinicka bolnica Merkur, Zagreb
UHC Zagreb, Zagreb
Columbia University Medical Center, New York
Faculty Hospital Kralovske Vinohrady, Prague
University of Rochester, Rochester
Georgetown University, Washington D.C.
Spitalul Clinic Colentina, Bucharest
Ospedale San Raffaele, Milan
Center for Cancer and Blood Disorders, Bethesda
Hospital Universitario La Princesa, Madrid
Hospital Gregorio Marañon, Madrid
Hospital Universitario Ramón Y Cajal, Madrid
Hospital 12 de Octubre, Madrid
AOU Maggiore della Carità, Novara
Hospital Universitario Puerta De Hierro, Madrid
Saint Francis Hospital, Greenville
Cancer Specialists of North Florida, Jacksonville
Memorial Healthcare System, Hollywood
Florida Cancer Specialists-South, Sarasota
CHU Bretonneau, Tours
Sarah Cannon Research Institute, Nashville
Azienda Ospedaliero Universitaria Policlinico di Modena, Modena
Gabrail Cancer Center Research, Canton
Signal Point Clinical Research Center, Middletown
Sarah Cannon Research Institute, Cincinnati
Franciscan Physician Network Oncology & Hematology, Indianapolis
Siouxland Hematology-Oncology Associates, LLP, Sioux City
CHRU de Lille, Hopital Claude Huriez, Lille
University Hospital, Brno
IRCCS Istituto Tumori, Bari
Faculty hospital Ostrava, Ostrava-Poruba
Hospital Saint-Louis, Paris
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas
Texas Oncology-Austin Midtown, Austin
Utah Cancer Specialists, Salt Lake City
Comprehensive Cancer Centers of Nevada, Las Vegas
UCSD Moores Cancer Center, La Jolla
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center, Fullerton
Central Coast Medical Oncology, Santa Maria
Fred Hutchinson Cancer Research Center, Seattle
Emergency County Clinical Hospital Brasov, Brasov
Hematology /Oncology Associates of Northern New Jersey, Morristown
Cancercare Manitoba - Maccharles Unit, Winnipeg
Sunnybrook Health Sciences Centre, Toronto
Princess Margaret Cancer Centre, Toronto
Hôpital du Sacré-Coeur de Montréal, Montreal
CHU de Québec - Hôpital de l'Enfant-Jésus, Québec
Faculty Hospital Hradec Kralove, Hradec Králové
Faculty Hospital Plzen, Pilsen
Ospedale Oncologico Armando Businco, Cagliari
Uniwersyteckie Centrum Kliniczne, Gdansk
Malopolskie Centrum Medyczne s.c., Krakow
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii, Lodz
Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii, Warsaw
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego, Warsaw
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku, Wroclaw
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw
Hospital Vall de Hebron, Barcelona
Hospital Clinic, Barcelona
University College London, London
East Kent Hospitals University NHS Foundation Trust, Canterbury
Royal Marsden NHS Trust, Sutton
University Hospital of Wales, Cardiff
Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust, Liverpool
Hammersmith Hospitals NHS Trust, London
Oxford University Hospitals, Oxford
University Hospital Southampton NHS Trust, Southampton
Royal Wolverhampton Hospital NHS Trust, New Cross Hospital, Wolverhampton
Lead Sponsor
Gilead Sciences
INDUSTRY