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

Last updated: October 19, 2018
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

3

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Treatment

Rituximab

Idelalisib

Bendamustine

Clinical Study ID

NCT01980888
GS-US-312-0123
2013-003313-17
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Documented diagnosis of B-cell CLL, with diagnosis established according toInternational 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

Exclusion

Key Exclusion Criteria:

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

  • Known presence of myelodysplastic syndrome

  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time ofrandomization

  • 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 daysprior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 311
Treatment Group(s): 4
Primary Treatment: Rituximab
Phase: 3
Study Start date:
February 05, 2014
Estimated Completion Date:
June 16, 2016

Connect with a study center

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Jarrett Street Specialist Centre

    North Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre, Department of Haematology, Level 6

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Chu Ucl Dinant Godinne

    Yvoir, Namur 5530
    Belgium

    Site Not Available

  • Z N A Stuivenberg

    Antwerpen, 2060
    Belgium

    Site Not Available

  • AZ Sint-Jan AV Brugge-Oostende

    Brugge, 8000
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Ghent- hematology

    Ghent, 9000
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UMHAT Georgi Stranski

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Cancercare Manitoba - Maccharles Unit

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C9
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Hôpital du Sacré-Coeur de Montréal

    Montréal, Quebec H4J 1C5
    Canada

    Site Not Available

  • CHU de Québec - Hôpital de l'Enfant-Jésus

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

  • General Hospital Eastern Health

    St. John's NL, A1B 3V6
    Canada

    Site Not Available

  • Klinicka bolnica Dubrava

    Zagreb, 10000
    Croatia

    Site Not Available

  • Klinicka bolnica Merkur

    Zagreb, 10000
    Croatia

    Site Not Available

  • UHC Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • Faculty hospital Ostrava

    Ostrava-Poruba, Moravian-Silesian 70852
    Czechia

    Site Not Available

  • University Hospital

    Brno, 62500
    Czechia

    Site Not Available

  • Faculty Hospital Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Faculty Hospital Plzen

    Plzen, 304 60
    Czechia

    Site Not Available

  • Faculty Hospital Kralovske Vinohrady

    Prague 10, 10034
    Czechia

    Site Not Available

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95100
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33076
    France

    Site Not Available

  • Hôpital Henri Mondor Unité Hémopathies Lymphoïdes

    Créteil, 94010
    France

    Site Not Available

  • CHRU de Lille, Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Hospital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Centre hospitalier lyon sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Centre d'investigation clinique Inserm CIC 1402 CHU Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

    Rennes Cedex, 35033
    France

    Site Not Available

  • IUCT Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • CHU Bretonneau

    Tours, 37044
    France

    Site Not Available

  • Szent Borbála Hospital

    Tatabánya, Komárom - Esztergom 2800
    Hungary

    Site Not Available

  • Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,

    Kaposvar, Somogy 7400
    Hungary

    Site Not Available

  • National Institute of Oncology

    Budapest, 1122
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest, 1083
    Hungary

    Site Not Available

  • University of Debrecen HSC Institute of internal Medicine, Department of Hematology

    Debrecen, 4032
    Hungary

    Site Not Available

  • Duke University Medical Center

    Durham, 27710
    Hungary

    Site Not Available

  • Pandy Kalman Hospital

    Gyula, 5700
    Hungary

    Site Not Available

  • University Of Pecs, Medical School

    Pecs, 7624
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika

    Szeged, 6725
    Hungary

    Site Not Available

  • IRCCS Istituto Tumori

    Bari, Puglia 70024
    Italy

    Site Not Available

  • Ospedale Oncologico Armando Businco

    Cagliari, 09121
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena, 41124
    Italy

    Site Not Available

  • AOU Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • Università degli Studi di Roma La Sapienza

    Rome, 00161
    Italy

    Site Not Available

  • Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej,

    Brzozow, Podkarpackie 36-200
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, Pomorskie 80-952
    Poland

    Site Not Available

  • Malopolskie Centrum Medyczne s.c.

    Krakow, 30-510
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział hematologiczny

    Legnica, 59-220
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii

    Lodz, 93-510
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii

    Warsaw, 02-507
    Poland

    Site Not Available

  • Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego

    Warszawa, 02-781
    Poland

    Site Not Available

  • Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 53-439
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Emergency County Clinical Hospital Brasov

    Brasov, 500326
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucharest, 20125
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi

    Iasi, 700348
    Romania

    Site Not Available

  • Hospital Germans Trias i Pujol - Institut Català d'Oncologia Badalona

    Badalona, Barcelona/Cataluña 08907
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clinic

    Barcelona, Cataluña 08036
    Spain

    Site Not Available

  • Hospital Vall de Hebron

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Site Not Available

  • ICO, Hospitalet de Llobregat

    Barcelona, 8908
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitario Puerta De Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital Universitario La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • University College London

    London, England WC1E 6BT
    United Kingdom

    Site Not Available

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Royal Marsden NHS Trust

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Hammersmith Hospitals NHS Trust

    London, W12 0HS
    United Kingdom

    Site Not Available

  • Oxford University Hospitals

    Oxford, OX37LE
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Royal Wolverhampton Hospital NHS Trust, New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center

    Fullerton, California 92835
    United States

    Site Not Available

  • Beaver Medical Group, L.P.

    Highland, California 92346
    United States

    Site Not Available

  • UCSD Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Long Beach, California 90813
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • West Valley Hematology Oncology Medical Group

    Northridge, California 91328
    United States

    Site Not Available

  • Coastal Integrative Cancer Care

    San Luis Obispo, California 93401
    United States

    Site Not Available

  • Sansum Clinic

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Central Coast Medical Oncology

    Santa Maria, California 93454
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • Cancer Center of Central Connecticut

    Southington, Connecticut 06489
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown University

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Florida Cancer Specialists-South

    Sarasota, Florida 34236
    United States

    Site Not Available

  • Florida Cancer Specialists-North

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • The US Oncology Network-Illinois Cancer Specialists-Niles-Chicagoland

    Niles, Illinois 60714-5905
    United States

    Site Not Available

  • Franciscan Physician Network Oncology & Hematology

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Montgomery Cancer Center

    Mount Sterling, Kentucky 40353
    United States

    Site Not Available

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89074
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hematology /Oncology Associates of Northern New Jersey

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Signal Point Clinical Research Center

    Middletown, Ohio 45042
    United States

    Site Not Available

  • Saint Francis Hospital

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Prairie Lakes Healthcare System Inc.

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology-Austin Midtown

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology-Fort Worth

    Fort Worth, Texas 76104-3927
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84103
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

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