Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

742

Participants

Timeline

Start Date

July 24, 2009

Primary Completion Date

June 15, 2016

Study Completion Date

June 15, 2016

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Everolimus

Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

DRUG

Everolimus Placebo

Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

Trial Locations (202)

11

Novartis Investigative Site, Jesus Maria

27

Novartis Investigative Site, San Isidro

652

Novartis Investigative Site, Saida

1010

Novartis Investigative Site, Caracas

1011

Novartis Investigative Site, Caracas

1090

Novartis Investigative Site, Vienna

1122

Novartis Investigative Site, Budapest

1140

Novartis Investigative Site, Vienna

3168

Novartis Investigative Site, Clayton

3220

Novartis Investigative Site, Geelong

4010

Novartis Investigative Site, Linz

4120

Novartis Investigative Site, Greenslopes

4810

Novartis Investigative Site, Douglas

6020

Novartis Investigative Site, Innsbruck

6301

Novartis Investigative Site, Beirut

6500

Novartis Investigative Site, Bellinzona

7400

Novartis Investigative Site, Kaposvár

7624

Novartis Investigative Site, Pécs

8091

Novartis Investigative Site, Zurich

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10408

Novartis Investigative Site, Gyeonggi-do

10700

Novartis Investigative Site, Bangkok

11009

Novartis Investigative Site, Cadiz

11426

Novartis Investigative Site, Riyadh

11527

Novartis Investigative Site, Athens

11566

Novartis Investigative Site, Cairo

12655

Novartis Investigative Site, Cairo

15213

University of Pittsburgh Medical Center SC-3, Pittsburgh

15215

Novartis Investigative Site, Dammam

15526

Novartis Investigative Site, Bad Saarow

16132

Novartis Investigative Site, Genova

20080

Novartis Investigative Site, Donostia / San Sebastian

20089

Novartis Investigative Site, Rozzano

20095

Novartis Investigative Site, Hamburg

20141

Novartis Investigative Site, Milan

21423

Novartis Investigative Site, Jeddah

24018

Blue Ridge Research Center at Roanoke Neurological Center SC, Roanoke

27157

Wake Forest University Baptist Medical Center Dept. of WFUHS, Winston-Salem

28006

Novartis Investigative Site, Madrid

28203

Levine Cancer Institute Oncology, Charlotte

28222

Novartis Investigative Site, Majadahonda

28223

Novartis Investigative Site, Pozuelo de Alarcón

29100

Novartis Investigative Site, Piacenza

29200

Novartis Investigative Site, Brest

29425

Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2), Charleston

29605

Cancer Centers of the Carolinas Cancer Centers of Carolinas (3, Greenville

30174

Novartis Investigative Site, Venezia

30607

University Cancer & Blood Center, LLC, Athens

31008

Novartis Investigative Site, Pamplona

31904

Columbus Regional, Columbus

33426

University Cancer Institute, Boynton Beach

33604

Novartis Investigative Site, Pessac

34093

Novartis Investigative Site, Istanbul

35516

Novartis Investigative Site, Al Mansurah

38039

Novartis Investigative Site, Talas / Kayseri

38104

University of Tennessee Cancer Institute SC-2, Memphis

38120

The West Clinic, Memphis

39008

Novartis Investigative Site, Santander

41013

Novartis Investigative Site, Seville

41100

Novartis Investigative Site, Modena

42123

Novartis Investigative Site, Reggio Emilia

42271

Novartis Investigative Site, Saint-Priest-en-Jarez

46010

Novartis Investigative Site, Valencia

46202

Indiana University Hospital IU Cancer Center, Indianapolis

49100

Novartis Investigative Site, Petah Tikva

50134

Novartis Investigative Site, Florence

51067

Novartis Investigative Site, Cologne

52074

Novartis Investigative Site, Aachen

53100

Novartis Investigative Site, Siena

53188

Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp., Waukesha

53717

Dean Health System, Madison

55905

Mayo Clinic - Rochester Dept. of MayoClinic-Rochester, Rochester

56126

Novartis Investigative Site, Pisa

60612

Rush University Medical Center Div. of Hematology & Oncology, Chicago

63110

Washington University School of Medicine Div. of Medical Oncology, St Louis

64020

Novartis Investigative Site, Monterrey

64239

Novartis Investigative Site, Tel Aviv

65124

Novartis Investigative Site, Pescara

70112

Tulane University Health Sciences Center Office of Clinical Research, New Orleans

71013

Novartis Investigative Site, San Giovanni Rotondo

72100

Novartis Investigative Site, Brindisi

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

73100

Novartis Investigative Site, Lecce

76104

The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD, Fort Worth

76508

Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care, Temple

77030

Baylor College of Medicine Dept.of Baylor College of Med., Houston

78258

South Texas Oncology and Hematology, PA South Texas Oncology (2), San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

80054

Novartis Investigative Site, Amiens Cedex1

80909

University of Colorado Health, Colorado Springs

81737

Novartis Investigative Site, München

85100

Novartis Investigative Site, Potenza

85224

Ironwood Cancer and Research Centers SC, Chandler

85925

Novartis Investigative Site, La Roche-sur-Yon

87042

Novartis Investigative Site, Limoges

89124

Novartis Investigative Site, Reggio Calabria

90033

USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4), Los Angeles

90110

Novartis Investigative Site, Songkhla

90146

Novartis Investigative Site, Palermo

91120

Novartis Investigative Site, Jerusalem

95124

Novartis Investigative Site, Catania

96049

Novartis Investigative Site, Bamberg

100021

Novartis Investigative Site, Beijing

100036

Novartis Investigative Site, Beijing

115478

Novartis Investigative Site, Moscow

119228

Novartis Investigative Site, Singapore

125167

Novartis Investigative Site, Moscow

129110

Novartis Investigative Site, Moscow

166378

Novartis Investigative Site, Beirut

166830

Novartis Investigative Site, Beirut

169608

Novartis Investigative Site, Singapore

169610

Novartis Investigative Site, Singapore

185019

Novartis Investigative Site, Petrozavodsk

191024

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

310003

Novartis Investigative Site, Hangzhou

510060

Novartis Investigative Site, Guangzhou

603000

Novartis Investigative Site, Nizhny Novgorod

610041

Novartis Investigative Site, Chengdu

3525408

Novartis Investigative Site, Haifa

5266202

Novartis Investigative Site, Ramat Gan

92093-0658

University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3), La Jolla

80204-4507

Denver Health & Hospital Authority CACZ885M2301, Denver

Unknown

Rocky Mountain Cancer Centers RMCC, Greenwood Village

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Bucaramanga

Novartis Investigative Site, Medellín

Novartis Investigative Site, Alexandria

Novartis Investigative Site, Cairo

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Grafton

Novartis Investigative Site, Wellington

01805

Lahey Clinic Dept of Lahey Clinic (3), Burlington

03756

Dartmouth Hitchcock Medical Center Dartmouth, Lebanon

77030-4009

University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18), Houston

05404

University of Vermont Office of Clinical Trials Res., Burlington

22908-0334

University of Virginia Health Systems SC-2, Charlottesville

B1900AWT

Novartis Investigative Site, La Plata

C1114AAN

Novartis Investigative Site, Buenos Aires

X5016KEH

Novartis Investigative Site, Córdoba

A-8700

Novartis Investigative Site, Leoben

80060-900

Novartis Investigative Site, Curitiba

90610-000

Novartis Investigative Site, Porto Alegre

13083-970

Novartis Investigative Site, Campinas

01224-000

Novartis Investigative Site, São Paulo

05403-000

Novartis Investigative Site, São Paulo

L6R 3J7

Novartis Investigative Site, Brampton

N1R 3G2

Novartis Investigative Site, Cambridge

L5M 2V8

Novartis Investigative Site, Mississauga

K1H 8L6

Novartis Investigative Site, Ottawa

M4C 3E7

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

J4V 2H1

Novartis Investigative Site, Greenfield Park

H1T 2M4

Novartis Investigative Site, Montreal

H4A 3J1

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

625 00

Novartis Investigative Site, Brno - Bohunice

500 05

Novartis Investigative Site, Hradec Králové

775 20

Novartis Investigative Site, Olomouc

100 34

Novartis Investigative Site, Prague

01307

Novartis Investigative Site, Dresden

711 10

Novartis Investigative Site, Heraklion Crete

115 27

Novartis Investigative Site, Athens

455 00

Novartis Investigative Site, Ioannina

H-9023

Novartis Investigative Site, Győr

H-6725

Novartis Investigative Site, Szeged

466-8650

Novartis Investigative Site, Nagoya

277-8577

Novartis Investigative Site, Kashiwa

790-8524

Novartis Investigative Site, Matsuyama

737-0023

Novartis Investigative Site, Kure

920-8641

Novartis Investigative Site, Kanazawa

160-0023

Novartis Investigative Site, Shinjuku-ku

602-8566

Novartis Investigative Site, Kyoto

980-8574

Novartis Investigative Site, Sendai

545-8586

Novartis Investigative Site, Osaka

565-0871

Novartis Investigative Site, Suita

411-8777

Novartis Investigative Site, Sunto-gun

104-0045

Novartis Investigative Site, Chuo-ku

135-8550

Novartis Investigative Site, Koto

811-1395

Novartis Investigative Site, Fukuoka

1107 2020

Novartis Investigative Site, Beirut

01120

Novartis Investigative Site, Mexico City

NO-0424

Novartis Investigative Site, Oslo

20-080

Novartis Investigative Site, Lublin

85-796

Novartis Investigative Site, Bydgoszcz

93-509

Novartis Investigative Site, Lodz

02-106

Novartis Investigative Site, Warsaw

833 10

Novartis Investigative Site, Bratislava

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08208

Novartis Investigative Site, Sabadell

08916

Novartis Investigative Site, Badalona

08003

Novartis Investigative Site, Barcelona

08028

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

06100

Novartis Investigative Site, Ankara

06460

Novartis Investigative Site, Ankara

07070

Novartis Investigative Site, Antalya

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY