Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT01980888
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
311 participants
INTERVENTIONAL
2014-02-05
2016-06-16
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Idelalisib+bendamustine+rituximab
Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
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+bendamustine+rituximab
Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior therapy for CLL other than corticosteroids for disease complications
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Exclusion Criteria
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* History of non-infectious pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
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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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 D.C., 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
Antwerp, , Belgium
AZ Sint-Jan AV Brugge-Oostende
Bruges, , 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
Montreal, Quebec, Canada
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec, 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 Králové, , Czechia
Faculty Hospital Plzen
Pilsen, , Czechia
Faculty Hospital Kralovske Vinohrady
Prague, , 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,
Kaposvár, Somogy County, 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
Pécs, , Hungary
Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika
Szeged, , Hungary
IRCCS Istituto Tumori
Bari, Apulia, 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
Gdansk, Pomeranian Voivodeship, 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
Warsaw, , 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, Catalonia, Spain
Hospital Clinic
Barcelona, Catalonia, 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
Countries
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Other Identifiers
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2013-003313-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-312-0123
Identifier Type: -
Identifier Source: org_study_id
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