Spots Global Cancer Trial Database for Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT01980888
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center, Fullerton, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Central Coast Medical Oncology, Santa Maria, California, United States
Georgetown University, Washington, District of Columbia, United States
Memorial Healthcare System, Hollywood, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Florida Cancer Specialists-South, Sarasota, Florida, United States
Franciscan Physician Network Oncology & Hematology, Indianapolis, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Hematology /Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Sarah Cannon Research Institute, Cincinnati, Ohio, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
St Vincent's Hospital, Sydney, Darlinghurst, New South Wales, Australia
Jarrett Street Specialist Centre, North Gosford, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Department of Haematology, Level 6, Bedford Park, South Australia, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Frankston Hospital, Frankston, Victoria, Australia
Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia
Z N A Stuivenberg, Antwerpen, , Belgium
AZ Sint-Jan AV Brugge-Oostende, Brugge, , Belgium
University Hospital Leuven, Leuven, , Belgium
Cancercare Manitoba - Maccharles Unit, Winnipeg, Manitoba, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada
CHU de Québec - Hôpital de l'Enfant-Jésus, Quebec City, Quebec, Canada
Klinicka bolnica Dubrava, Zagreb, , Croatia
Klinicka bolnica Merkur, Zagreb, , Croatia
UHC Zagreb, Zagreb, , Croatia
Faculty hospital Ostrava, Ostrava-Poruba, Moravian-Silesian, Czechia
University Hospital, Brno, , Czechia
Faculty Hospital Hradec Kralove, Hradec Kralove, , Czechia
Faculty Hospital Plzen, Plzen, , Czechia
Faculty Hospital Kralovske Vinohrady, Prague 10, , Czechia
CHRU de Lille, Hopital Claude Huriez, Lille, , France
Hospital Saint-Louis, Paris, , France
CHU Bretonneau, Tours, , France
Szent Borbála Hospital, Tatabánya, Komárom - Esztergom, Hungary
Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,, Kaposvar, Somogy, Hungary
Semmelweis University, Budapest, , Hungary
National Institute of Oncology, Budapest, , Hungary
University of Debrecen HSC Institute of internal Medicine, Department of Hematology, Debrecen, , Hungary
Pandy Kalman Hospital, Gyula, , Hungary
University Of Pecs, Medical School, Pecs, , Hungary
Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika, Szeged, , Hungary
IRCCS Istituto Tumori, Bari, Puglia, Italy
Ospedale Oncologico Armando Businco, Cagliari, , Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico di Modena, Modena, , Italy
AOU Maggiore della Carità, Novara, , Italy
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomorskie, Poland
Malopolskie Centrum Medyczne s.c., Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii, Lodz, , Poland
Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii, Warsaw, , Poland
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego, Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku, Wroclaw, , Poland
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw, , Poland
Emergency County Clinical Hospital Brasov, Brasov, , Romania
Spitalul Clinic Colentina, Bucharest, , Romania
Hospital Vall de Hebron, Barcelona, Cataluña, Spain
Hospital Clinic, Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
ICO, Hospitalet de Llobregat, Barcelona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
Hospital Universitario Ramón Y Cajal, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta De Hierro, Madrid, , Spain
University College London, London, England, United Kingdom
East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, United Kingdom
Royal Marsden NHS Trust, Sutton, Surrey, United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust, Liverpool, , United Kingdom
Hammersmith Hospitals NHS Trust, London, , United Kingdom
Oxford University Hospitals, Oxford, , United Kingdom
University Hospital Southampton NHS Trust, Southampton, , United Kingdom
Royal Wolverhampton Hospital NHS Trust, New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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