Non Hodgkin Lymphoma Clinical Trial

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
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

Key Exclusion Criteria:

Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

311

Study ID:

NCT01980888

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 89 Locations for this study

See Locations Near You

St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
Fullerton California, 92835, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
Central Coast Medical Oncology
Santa Maria California, 93454, United States
Georgetown University
Washington District of Columbia, 20007, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
Florida Cancer Specialists-South
Sarasota Florida, 34236, United States
Franciscan Physician Network Oncology & Hematology
Indianapolis Indiana, 46237, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89074, United States
Hematology /Oncology Associates of Northern New Jersey
Morristown New Jersey, 07962, United States
Columbia University Medical Center
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Sarah Cannon Research Institute
Cincinnati Ohio, 45242, United States
Signal Point Clinical Research Center
Middletown Ohio, 45042, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology-Austin Midtown
Austin Texas, 78705, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Utah Cancer Specialists
Salt Lake City Utah, 84103, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
St Vincent's Hospital, Sydney
Darlinghurst New South Wales, 2010, Australia
Jarrett Street Specialist Centre
North Gosford New South Wales, 2250, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Flinders Medical Centre, Department of Haematology, Level 6
Bedford Park South Australia, 5042, Australia
Ashford Cancer Centre Research
Kurralta Park South Australia, 5037, Australia
Queen Elizabeth Hospital
Woodville South South Australia, 5011, Australia
Frankston Hospital
Frankston Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong Victoria, 3220, Australia
Z N A Stuivenberg
Antwerpen , 2060, Belgium
AZ Sint-Jan AV Brugge-Oostende
Brugge , 8000, Belgium
University Hospital Leuven
Leuven , 3000, Belgium
Cancercare Manitoba - Maccharles Unit
Winnipeg Manitoba, R3E 0, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hôpital du Sacré-Coeur de Montréal
Montréal Quebec, H4J 1, Canada
CHU de Québec - Hôpital de l'Enfant-Jésus
Quebec City Quebec, G1J 1, Canada
Klinicka bolnica Dubrava
Zagreb , 10000, Croatia
Klinicka bolnica Merkur
Zagreb , 10000, Croatia
UHC Zagreb
Zagreb , 10000, Croatia
Faculty hospital Ostrava
Ostrava-Poruba Moravian-Silesian, 70852, Czechia
University Hospital
Brno , 62500, Czechia
Faculty Hospital Hradec Kralove
Hradec Kralove , 500 0, Czechia
Faculty Hospital Plzen
Plzen , 304 6, Czechia
Faculty Hospital Kralovske Vinohrady
Prague 10 , 10034, Czechia
CHRU de Lille, Hopital Claude Huriez
Lille , 59037, France
Hospital Saint-Louis
Paris , 75010, France
CHU Bretonneau
Tours , 37044, France
Szent Borbála Hospital
Tatabánya Komárom - Esztergom, 2800, Hungary
Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,
Kaposvar Somogy, 7400, Hungary
Semmelweis University
Budapest , 1083, Hungary
National Institute of Oncology
Budapest , 1122, Hungary
University of Debrecen HSC Institute of internal Medicine, Department of Hematology
Debrecen , 4032, Hungary
Pandy Kalman Hospital
Gyula , 5700, Hungary
University Of Pecs, Medical School
Pecs , 7624, Hungary
Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika
Szeged , 6725, Hungary
IRCCS Istituto Tumori
Bari Puglia, 70024, Italy
Ospedale Oncologico Armando Businco
Cagliari , 09121, Italy
Ospedale San Raffaele
Milan , 20132, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena , 41124, Italy
AOU Maggiore della Carità
Novara , 28100, Italy
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomorskie, 80-95, Poland
Malopolskie Centrum Medyczne s.c.
Krakow , 30-51, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii
Lodz , 93-51, Poland
Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii
Warsaw , 02-50, Poland
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
Warszawa , 02-78, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku
Wroclaw , 50-36, Poland
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw , 53-43, Poland
Emergency County Clinical Hospital Brasov
Brasov , 50032, Romania
Spitalul Clinic Colentina
Bucharest , 20125, Romania
Hospital Vall de Hebron
Barcelona Cataluña, 08035, Spain
Hospital Clinic
Barcelona Cataluña, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 8041, Spain
ICO, Hospitalet de Llobregat
Barcelona , 8908, Spain
Hospital Universitario La Princesa
Madrid , 28006, Spain
Hospital Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario Ramón Y Cajal
Madrid , 28033, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Puerta De Hierro
Madrid , 28222, Spain
University College London
London England, WC1E , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury Kent, CT1 3, United Kingdom
Royal Marsden NHS Trust
Sutton Surrey, SM2 5, United Kingdom
University Hospital of Wales
Cardiff , CF14 , United Kingdom
Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust
Liverpool , L7 8X, United Kingdom
Hammersmith Hospitals NHS Trust
London , W12 0, United Kingdom
Oxford University Hospitals
Oxford , OX37L, United Kingdom
University Hospital Southampton NHS Trust
Southampton , SO16 , United Kingdom
Royal Wolverhampton Hospital NHS Trust, New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

311

Study ID:

NCT01980888

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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