Spots Global Cancer Trial Database for Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
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Trial Identification
Brief Title: Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Official Title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Study ID: NCT02044822
Study Description
Brief Summary: The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. 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 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Innovative Clinical Research Institute, Whittier, California, United States
Rocky Mountain Cancer Centers, Boulder, Colorado, United States
The University of Chicago Medicine, Chicago, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Duke University, Durham, North Carolina, United States
GHS Cancer Institute, Greenville, North Carolina, United States
Compass Oncology, Portland, Oregon, United States
Willamette Valley Cancer Center and Research Institute, Springfield, Oregon, United States
Hospital of the University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
St Vincent's Hospital, Sydney, Darlinghurst, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
St Vincent's Hospital, Melbourne, Fitzroy, Victoria, Australia
Liverpool Hospital, Liverpool, , Australia
Innsbruck University Hospital, Inner Medicine,, Innsbruck, , Austria
Univ. Klinik für Innere Medizin III LKH, Salzburg, , Austria
Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie, Vienna, , Austria
AZ Sint-Jan AV Brugge-Oostende, Brugge, , Belgium
University Hospital Leuven, Leuven, , Belgium
University Hospital, Brno, , Czechia
Faculty Hospital Hradec Kralove, Hradec Kralove, , Czechia
Hemato-Onkologicka Klinika Fn, Olomuc, , Czechia
Faculty hospital Ostrava, Ostrava-Poruba, , Czechia
Faculty Hospital Kralovske Vinohrady, Prague 10, , Czechia
Vseobecna Fakultim Nemocnice, Praha, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Centre Hospitalier Universitaire Hôpital Avicenne, Bobigny, , France
CHRU de Lille, Hopital Claude Huriez, Lille, , France
Centre Hospitalier Universitaire Nancy, Nancy, , France
Hopital Pitie-Salpetriere, Paris cedex 13, , France
University of Debrecen HSC Institute of internal Medicine, Department of Hematology, Debrecen, , Hungary
Institute of Hematology "L. e A. Seràgnoli", Bologna, , Italy
A.O.Spedali Civili Brescia, Brescia, , Italy
A.O.Niguarda Ca' Granda, Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico di Modena, Modena, , Italy
SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga, Orbassano, , Italy
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomorskie, Poland
Szpital Specjalistyczny w Brzozowie, Brzozow, , Poland
Malopolskie Centrum Medyczne s.c., Krakow, , Poland
Wojewodzki Szpital Specjalistyczny, Lodz, , Poland
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego, Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny, Wroclaw, , Poland
Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria, Lisbon, , Portugal
IPO Porto Francisco Gentil, E.P.E, Porto, , Portugal
Emergency County Clinical Hospital Brasov, Brasov, , Romania
Spitalul Clinic Colentina, Bucharest, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Clinic, Barcelona, Cataluña, Spain
Hospital Universitario Puerta De Hierro, Madrid, , Spain
Hospital Clinico Universitario De Valencia (Chuv), Valencia, , Spain
Saint James's University Hospital, Leeds, , United Kingdom
Royal Liverpool & Broadgreen Univ. Hospitals, Liverpool, , United Kingdom
University Hospital Southampton NHS Trust, Southampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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