Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

PHASE3TerminatedINTERVENTIONAL
Enrollment

475

Participants

Timeline

Start Date

January 2, 2013

Primary Completion Date

May 17, 2016

Study Completion Date

May 17, 2016

Conditions
Indolent Non-Hodgkin's Lymphomas
Interventions
DRUG

Idelalisib

150 mg tablet administered orally twice daily

DRUG

Rituximab

375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)

DRUG

Bendamustine

90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)

DRUG

Placebo

Tablet administered orally twice daily

Trial Locations (144)

404

China Medical University Hospital, Taichung

500

Changhua Christian Hospital, Changhua

2031

Prince of Wales Hospital, Randwick

3011

Western Hospital, Footscray

3065

Saint Vincent's Hospital, Fitzroy

3128

Box Hill Hospital, Box Hill

3168

Monash Medical Centre, Clayton

4101

Haematology and Oncology Clinics of Australia Gold Coast, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

5037

Adelaide Cancer Centre, Kurralta Park

6000

Royal Perth Hospital, Perth

10002

National Taiwan University Hospital, Taipei

10065

Weill Cornell Medical College, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

10967

Vivantes Klinikum am Urban, Berlin

11733

North Shore Hematology/Oncology Associates, East Setauket

13273

Institut Paoli Calmettes, Marseille

13353

Charite - Campus Virchow, Berlin

16132

IRCCS Azienda Ospedaliera Universitaria San Martino, Genova

20132

Ospedale San Raffaele-IRCCS, Milan

20162

Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan

25123

Spedali Civili Di Brescia Azienda Ospedaliera, Brescia

28006

Hospital Universitario La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañon, Madrid

28100

"Azienda Ospedaliero Universitaria (AOU) Maggiore della Carita di Novara", Novara

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29100

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto, Piacenza

29425

Hollings Cancer Center, Charleston

29607

Bon Secours Saint Francis Hospital, Greenville

29609

Centre Hospitalier Universitaire Brest, Brest

30060

Northwest Georgia Oncology Centers, PC, Marietta

31096

Rambam Health Corp., Haifa

32256

Cancer Specialists of North Florida, Jacksonville

33076

Institut Bergonié, Bordeaux

33081

Centro di Riferimento Oncologico di Aviano, Aviano

33442

Sylvester Comprehensive Cancer Center/UMHC, Deerfield Beach

34117

Gemeinschaftspraxis Dres. Söling Und Siehl, Kassel

35805

Clearview Cancer Institute, Huntsville

37007

Hospital Clínico Universitario de Salamanca, Salamanca

37044

Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau, Tours

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

44093

Hôpital Hôtel-Dieu, Nantes

45042

Signal Point Clinical Research Center, LLC, Middletown

46026

Hospital Universitari i Politecnic La Fé de Valencia, Valencia

53100

Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte, Siena

53226

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

54308

Aurora BayCare Medical Center, Green Bay

57085

CHR Metz, Metz

59385

Centre Hospitalier de Dunkerque, Dunkirk

60435

Joliet Oncology Hematology Associates Ltd., Joliet

60612

Rush University Medical Center, Chicago

61122

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro

67098

Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre, Strasbourg

67214

Cancer Center of Kansas, Wichita

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70403

National Cheng-Kung University Hospital, Tainan City

72000

Centre Jean Bernard, Le Mans

75015

Hôpital Necker-Enfants Malades, Paris

75246

Charles A. Sammons Cancer Center, Dallas

76022

Texas Oncology, P.A., Bedford

76038

Centre Henri-Becquerel, Rouen

76210

Texas Oncology, P.A., Denton

78054

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen

78234

Brooke Army Medical Center, Fort Sam Houston

78278

Barzilai Medical Center, Ashkelon

81377

Klinikum der Ludwig-Maximilians-Universität München, München

84101

Soroka University Medical Center, Beersheba

85224

Ironwood Cancer and Research Center, Chandler

85925

Centre Hospitalier Départmental La Roche sur Yon, La Roche-sur-Yon

86021

Centre Hospitalier Universitaire de Poitiers, Poitiers

90277

Cancer Care Associates, Redondo Beach

90813

Pacific Shores Medical Group, Long Beach

91120

Hadassah Medical Organization, Ein Kerem, Jerusalem

92835

Saint Jude Heritage Healthcare (TORI), Fullerton

93105

Cancer Center of Santa Barbara, Santa Barbara

93309

Comprehensive Blood and Cancer Center (Bakersfield), Bakersfield

93401

San Luis Obispo Oncology and Hematology, San Luis Obispo

93454

Central Coast Medical Oncology Group, Santa Maria

94589

Kaiser Permanente Vallejo Medical Center, Vallejo

94805

Institut Gustave Roussy, Villejuif

95403

St Joseph Heritage Healthcare System, Santa Rosa

98104

Swedish Medical Center, Seattle

98405

Northwest Medical Specialists, Tacoma

115478

N. N. Blokhin Russian Cancer Research Center, Moscow

140012

Saratov State Medical University, Saratov

191024

FGU Russian Scientific Research Institute of Hematology and Transfusiology, Saint Petersburg

197022

Saint Petersburg I.P. Pavlov State Medical University, Saint Petersburg

197341

"FSI V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies", Saint Petersburg

390039

Ryazan Regional Clinical Hospital, Ryazan

400138

"State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1", Volgograd

603126

Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, Nizhny Novgorod

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

620137

Central City Hospital # 7, Yekaterinburg

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

78550-8321

Texas Oncology, P.A., Harlingen

78596-6608

Texas Oncology, P.A., Weslaco

T2N 2T9

Tom Baker Cancer Center, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V3L 3W4

Fraser Clinical Trials, Inc., New Westminster

V5Z 4E6

BC Cancer Agency - Vancouver Centre, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research, Halifax

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

J4V 2H1

Hôpital Charles Lemoyne, Greenfield Park

H4A 3JI

McGill University Health Centre, Montreal

G1J 1Z4

Centre Hospitalier Affilie Universitaire de Quebec, Québec

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

R3E 0V9

CancerCare Manitoba, Winnipeg

708 52

Fakultní Nemocnice Ostrava, Ostrava - Poruba

625 00

Fakultní nemocnice Brno, Brno

500 05

Fakultní nemocnice Hradec Králové, Hradec Králové

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

30-510

Malopolskie Centrum Medyczne S.C., Krakow

93-510

Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi, Lódz

20-081

Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku, Lublin

10-228

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim, Olsztyn

76-200

Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku, Słupsk

02-507

Centralny Szpital Kliniczny MSW w Warszawie, Warsaw

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

02-781

Centrum Onkologii i Hipertermii, Warsaw

602-715

Dong-A University Medical Center, Busan

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

141 86

Karolinska Universitetssjukhuset, Huddinge

551 85

Länssjukhuset Ryhov, Jönköping

CT1 3NG

Kent and Canterbury Hospital, Canterbury

CV2 2DX

University Hospital Coventry, Coventry

BH7 7DW

Royal Bournemouth General Hospital, Dorset

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

EC1M 6BQ

Barts and The London NHS Trust, London

NW1 2PG

University College London Hospitals National Health Society Foundation Trust, London

SE1 9RT

Guys and Saint Thomas NHS Foundation Trust, London

W12 0NN

Imperial College Healthcare NHS Trust, London

ME16 9QQ

Maidstone Hospital, Maidstone

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

OX3 7LE

Oxford University Hospitals NHS Trust, Oxford

SO16 6YD

Southampton General Hospital, Southampton

HA6 2RN

Mount Vernon Hospital, Middlesex

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY