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

PHASE3TerminatedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

January 16, 2013

Primary Completion Date

May 18, 2016

Study Completion Date

May 18, 2016

Conditions
Indolent Non-Hodgkin's Lymphomas
Interventions
DRUG

Placebo

Tablets administered orally twice daily

DRUG

Rituximab

375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)

DRUG

Idelalisib

150 mg tablets administered orally twice daily

Trial Locations (103)

1083

Semmelweis Egyetem, Budapest

1122

Országos Onkológiai Intézet, Budapest

3011

Western Hospital, Footscray

3065

Saint Vincent's Hospital, Fitzroy

3128

Box Hill Hospital, Box Hill

3168

Monash Medical Centre, Clayton

4032

Debreceni Egyetem Orvos-és Egészségtudományi Centrum, Debrecen

4064

Haematology and Oncology Clinics of Australia at Chermside, Milton

6000

Royal Perth Hospital, Perth

6150

Fiona Stanley Hospital, Murdoch

7400

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

9700

Markusovszky Egyetemi Oktatókórház, Szombathely

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Weill Cornell Medical College, New York

10126

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

10467

Montefiore Medical Center, The Bronx

11490

Tri-Service General Hospital, Taipei

19104

Perelman Center for Advanced Medicine, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

22601

Shenandoah Oncology Associates, PC, Winchester

28100

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

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29609

Centre Hospitalier Universitaire Brest, Brest

33081

Centro di Riferimento Oncologico di Aviano, Pordenone

33604

University Hospital of Bordeaux, Pessac

33612

Moffitt Cancer Center, Tampa

33916

Florida Cancer Specialists and Research Institute, Fort Myers

34119

Gemeinschaftspraxis Dres. Söling Und Siehl, Kassel

35805

Clearview Cancer Institute, Huntsville

37203

Sarah Cannon Cancer Center, Nashville

37404

Tennessee Oncology, PLLC, Chattanooga

40138

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

44093

Hôpital Hôtel-Dieu, Nantes

44109

MetroHealth Medical Center, Cleveland

45042

Signal Point Clinical Research Center, LLC, Middletown

48201

Wayne State University, Detroit

49100

Rabin Medical Center, Petah Tikva

53226

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

57252

Prairie Lakes Healthcare System, Watertown

59037

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille

59385

Centre Hospitalier de Dunkerque, Dunkirk

61100

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro

67214

Cancer Center of Kansas, Wichita

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75015

Hôpital Necker-Enfants Malades, Paris

76022

Texas Oncology, P.A., Bedford

76104

Center for Cancer and Blood Disorders, PC, Fort Worth

78052

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

78157

Centre Hospitalier de Versailles, Le Chesnay

78234

Brooke Army Medical Center, Fort Sam Houston

83301

Chang Gung Memorial Hospital (CGMH), Kaohsiung City

85224

Ironwood Cancer and Research Center, Chandler

86000

Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie, Poitiers

90095

UCLA Medical Center, Los Angeles

90277

Cancer Care Associates, Redondo Beach

90813

Pacific Shores Medical Group, Long Beach

91010

City of Hope Cancer Center, Duarte

91120

Hadassah Medical Organization, Ein Kerem, Jerusalem

92835

Saint Jude Heritage Healthcare, Fullerton

93105

Cancer Center of Santa Barbara, Santa Barbara

93454

Central Coast Medical Oncology Group, Santa Maria

98101

Virginia Mason Medical Center, Seattle

98405

Northwest Medical Specialties, PLLC, Tacoma

169608

Singapore General Hospital, Singapore

169610

National Cancer Centre Singapore, Singapore

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

258500

Gleneagles Medical Centre, Singapore

390039

Ryazan Regional Clinical Hospital, Ryazan

603126

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

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

1040045

National Cancer Center Hospital, Chuo-ku

1058470

Toranomon Hospital, Minato-ku

4600001

National Hospital Organization Nagoya Medical Center, Nagoya

9808574

Tohoku University Hospital, Sendai

06457

Middlesex Hospital Cancer Center, Middletown

89169-3321

Comprehensive Cancer Centers of Nevada, Las Vegas

SA 5037

Adelaide Cancer Centre, Kurralta Park

500 05

Fakultní nemocnice Hradec Králové, Hradec Králové

464-8681

Aichi Cancer Center Hospital, Nagoya

467-8681

Nagoya City University Hospital, Nagoya

811-1395

National Hospital Organization Kyushu Cancer Center, Minamiku

650-0047

Kobe City Medical Center General Hospital, Kobe

259-1193

Tokai University Hospital, Isehara-shi

860-0008

National Hospital Organization Kumamoto Medical Center, Chuo-ku

700-8558

Okayama University Hospital, Okayama

545-8586

Osaka City University Hospital, Osaka

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

30-510

Malopolskie Centrum Medyczne S.C., Krakow

10-228

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

02-781

Centrum Onkologii i Hipertermii, Warsaw

4099-001

Hospital Geral de Santo António do Centro Hospitalar do Porto, Porto

022328

Institutul Clinic Fundeni, Bucharest

410 028

Saratov State Medical University, Saratov

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-876

Asan Medical Center, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

205 02

Skånes Universitetssjukhus, Malmö, Malmo

EC1A 7BE

Barts and The London NHS Trust, London

HA6 2RN

Mount Vernon Hospital, Middlesex

SR4 7TP

Sunderland Royal Infirmary, Sunderland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01732913 - Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas | Biotech Hunter | Biotech Hunter