A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

317

Participants

Timeline

Start Date

January 27, 2009

Primary Completion Date

October 27, 2020

Study Completion Date

October 27, 2020

Conditions
B-cell Chronic Lymphocytic Leukemia
Interventions
DRUG

Lenalidomide

Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

DRUG

Placebo

Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Trial Locations (241)

8

St James's Hospital, Dublin

1000

Institut Jules Bordet, Brussels

1083

Semmelweis Egyetem, Budapest

1190

Medical University of Vienna Internalmedicine 1, Hematology, Vienna

1200

Cliniques Universitaires St Luc, Brussels

1309

North Shore Hospital, Takapuna

1640

Middlemore Clinical Trials, Manukau

2050

Royal Prince Alfred Hospital, Camperdown

2065

Royal North Shore HospitalDepartment of HematologyLevel 4, St Leonards

2100

Rigshospitalet University Hospital, Copenhagen

2139

Concord Hospital, Concord

2193

University Witwatersrand Oncology, Parktown

2217

Clinical Trials Unit The St George Hospital, Kogarah

2751

Nepean Hospital, Kingswood, NSW

3000

UZ Leuven, Leuven

3006

Peter MacCallum Cancer Centre, East Melbourne

3065

St. Vincent Hospital, Fitzroy

3199

Frankston Hospital, Farkston

4010

Hospital Bamherzige Schwestern, Linz

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

4101

Haematology and Oncology Clinics of Australasia, South Brisbane

5011

The Queen Elizabeth Hospital, Woodville

5042

Flinders Medical Centre, Bedford Park

5530

CHU Mont -Godinne, Yvoir

6009

Sir Charles Gairdner Hospital, Nedlands

6020

Universitaetsklinik Innsbruck, Innsbruck

6720

Szegedi TudomanyegyetemII Belgyogyaszati Klinika, Szeged

7100

Hopital de Jolimont, Haine-Saint-Paul

Vejle Hospital, Vejle

7400

Kaposi Mor Oktato Korhaz, Kaposvár

7624

Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar, Pécs

8000

AZ Sint-Jan AV Brugge, Bruges

8500

AZ Groeninge, Kortrijk

9000

UZ Gent Hematology, Ghent

9024

Petz Aladar Country Hospital, Győr

10126

Osp. S.Giovanni Battista Le Molinette, Torino

10595

Westchester County Medical Center, Valhalla

11042

Biomedical Research Alliance of New York, LLC, New Hyde Park

11501

Winthrop University Hospital, Mineola

11883

Stockholm South Hospital, Stockholm

12203

Charite, Campus Benjamin Franklin, Medizinische Klinik III, Berlin

12808

General Faculty Hosital1.Internal Clinic, Prague

13215

SUNY Upstate Medical University Medicine Oncology, Syracuse

14186

Karolinska University, Stockholm

14263

Roswell Park Cancer Institute, Buffalo

15224

Western Pennsylvania Hospital, Pittsburgh

15236

Innere Medizin Klinikum Frankfurt Oder GmBH, Frankfurt (Oder)

16132

Azienda Ospedaliera San Martino, Genova

17325

Gettysburg Cancer Center, Gettysburg

18101

Ha'Emek Medical Center, Afula

19001

Abington Memorial Hospital, Abington

19090

Abington Hematology Oncology Associates Inc, Willow Grove

19102

Drexel University, College of Medicine, Clinical Research Group, Philadelphia

20014

Hospital Donostia, Donostia / San Sebastian

20122

IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan

20127

Instituto Biomedico de Investigacion AC, Aguascalientes

20132

Fondazione Centro San Raffaele del Monte Tabor, Milan

20141

Istituto Oncologico Europeo, Milan

22100

Western Galilee Hospital, Nahariya

25123

AO Spedali Civili di Brescia, Brescia

27157

Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center, Winston-Salem

28006

Hospital Universitario de la Princesa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital 12 de Octubre, Madrid

28046

Hospital La Paz, Madrid

28100

Universita del Piemonte Orientale, Novara

28222

Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda

29010

Virgen de la Victoria Hospital Malaga, Málaga

29150

M. Francisco Gonzalez, MD, PA, Sumter

29403

Charleston Hematology Oncology P.A., Charleston

30008

Hospital General Universitario Morales Messeguer, Murcia

30060

Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute, Marietta

30460

Faculty Hospital Plzen, Pilsen

30625

Medizinische Hochschule Hannover, Hanover

30901

Augusta Oncology Associates, P.C., Augusta

31048

Bnei Zion Medical Center, Haifa

31096

Rambam Health Care Campus, Haifa

32224

Mayo Clinic - Jacksonville, Jacksonville

32778

Florida Cancer Specialist, Tavares

Florida Hospital Cancer Institute Waterman, Tavares

33021

Memorial Hospital, Hollywood

33076

Bergonie Institut, Bordeaux

33486

Boca Raton Community Hospital, Boca Raton

34613

Pasco Hernando Oncology Associates, PA, Brooksville

35128

Universita degli Studi di Padova, Padua

36100

Ospedale San Bortolo di Vicenza, Vicenza

37007

Hospital Universitario de Salamanca, Salamanca

37044

Hopital Bretonneau, Tours

37203

Sarah Cannon Cancer Center, Nashville

38043

CHU Hopital Michallon, Grenoble

39008

Hospital Universitario Marques de Valdecilla, Santander

41100

Azienda Ospedaliero Universitaria di Modena, Modena

43235

Hematology Oncology Consultants, Inc., Columbus

44093

Cetre Hospitalier Hotel-Dieu, Nantes

44100

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

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

44281

Meir Medical Center, Kfar Saba

44622

Gabrail Cancer Center Research, Dover

44691

Trilogy Cancer Care, Wooster

44718

Gabrail Cancer Center Research, Canton

45122

Universitaetsklinikum EssenZentrum fuer Innere Medizin, Essen

45219

The Christ Hospital, Cincinnati

45242

Oncology Hematology Care, Cincinnati

46010

Hospital Clinico Universitario, Valencia

47150

Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services, New Albany

48149

Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis, Münster

49100

Rabin Medical Center, Petah Tikva

50010

McFarland Clinic, Ames

50139

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Klinikum der Universitat zu Koln, Cologne

51092

CHU de Reims, Reims

52621

Sheba Medical Center, Tel Litwinsky

53100

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena

54601

Gundersen Clinic Lutheran Hospital, La Crosse

56068

Praxis fuer Haematologie und Onkologie Koblenz, Koblenz

60020

Ospedale Umberto I, Torrette Di Ancona

60064

North Chicago VA Medical Center, North Chicago

60076

Hematology Oncology Assoc. of IL Orchard Research LLC, Skokie

60141

Edward Hines Jr VA Hospital, Hines

60611

Northwestern University, Division of Hematology Oncology, Dept. of Medicine, Chicago

60612

Rush University Medical Center, Chicago

63000

CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire, Clermont-Ferrand

64239

Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv

68161

Mannheimer Onkologie Praxis, Mannheim

69495

Centre Hospitalier Lyon Sud, Lyon

70121

Ochsner Medical Institutions, New Orleans

70124

Azienda Ospedaliera Poloclinico di Bari, Bari

Istituto dei Tumori Giovanni Paolo II di Bari, Bari

71100

Azienda Ospedaliero Universitaria OORR Foggia, Foggia

74101

Poliklinika Agel Novy Jicin, Nový Jičín

75390

UT Southwestern Medical Center, Dallas

76038

CLCC H BecquerelHematology, Rouen

76100

Kaplan Medical Center, Rehovot

78278

Barzilai Medical Center, Ashkelon

79106

Universitaetsklinikum FreiburgInnere Med.1, Haematologie, Freiburg im Breisgau

80045

University of Colorado Hospital, Aurora

80131

Ospedale Cardarelli, Naples

Policlinico Universitario Federico II, Naples

80804

Stadtisches Klinikum Munchen GmbH, München

81675

TU München - Klinikum rechts der Isar, München

84101

Soroka University Medical Center, Beersheba

85054

Mayo Clinic - Arizona, Phoenix

85100

Azienda Ospedaliera Ospedale San Carlo, Potenza

86021

CHU La Miletrie, Poitiers

87100

Azienda Ospedaliera Annunziala, Cosenza

88100

A.O. Pugliese Ciaccio, Catanzaro

89081

University Hospital of Ulm, Ulm

89106

Nevada Cancer Research Foundation, Las Vegas

91031

Shaare Zedek Medical Center, Jerusalem

92120

Kaiser Permanente Medical Group, San Diego

92123

Sharp Memorial Hospital, San Diego

92708

Pacific Coast Hematology Oncology, Fountain Valley

93009

Hopital Aviecenne, Bobigny

94305

Stanford University Stanford, Stanford

95124

Azienda Ospedaliera Vittorio Emanuele-Ferrarotto, Catania

97227

Kaiser Permanente Northwest Oncology Hematology, Portland

98104

Swedish Cancer Institute, Seattle

98801

Wenatchee Valley Hospital and Clinics, Wenatchee

115447

Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl, Moscow

123182

State Budgetary Institution of the City of Moscow, Moscow

129128

NUZ Central Clinical Hospital, Moscow

163045

Archangelsk Regional Clinical Hospital, Arkhangelsk

191024

FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency, Saint Petersburg

194291

GUS Leningrad Regional Clinical Hospital, Saint Petersburg

197022

St. Petersburg Pavlov State Medical Univ, Saint Petersburg

197341

Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies, Saint Petersburg

249036

Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so, Obninsk

300079

Spitalul Clinic Municipal de Urgenta Timisoara, Timișoara

400138

GUZ Volgograd Regional Clinical Oncology, Volgograd

410012

Saratov State Medical University, Saratov

420012

GMU Republic clinical hospital, Kazan'

550245

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu

603126

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

620102

State Healthcare Institution Sverdlovsk regional clinical hospital 1, Yekaterinburg

630051

MUZ City Clinical Hospital 2, Novosibirsk

659010

City Hospital 8, Barnaul

660022

Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk

700111

Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi, Iași

80218-1210

Rocky Mountain Cancer Center, Denver

06062

Cancer Center of Central Connecticut, Plainville

60426-3558

Ingalls Memorial Hospital, Harvey

51101-1733

Siouxland Hematology-Oncology Associates, LLP, Sioux City

02114

Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital, Boston

07601

The Cancer Center, Hackensack University Medical Center, Hackensack

5000 SA

IMVS, Adelaide

E2L 4L2

Regional Health Authority B-Saint John Regional Hospital, Saint John

A1B 3V6

General Hospital, Eastern Health, St. John's

B3H 1V7

CDHA Centre for Clinical Research, Halifax

M5G 2M9

Princess Margaret Hospital, Toronto

H2W 1S6

McGill University, Montreal

H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

Unknown

CIUSSS de l'Est-de-l'Ile-de-Montreal, Montreal/Quebec

Oncomedica S.A., Montería

Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza, Tatabánya

Midwestern Regional Hospital, Limerick

Christchurch Hospital, Christchurch

Groote Schuur Hospital, Cape Town

Mary Potter Oncology Centre, Pretoria

Wilgers Oncology CentreWilgrers Hospital, Pretoria

G1J 1Z4

Hopital De L'Enfant-Jesus, Québec

625 00

Interni hematoonkologicka klinika, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

100 00

Faculty Hospital Kralovske Vinohrady, Prague

DK-5000

Odense University Hospital, Odense

06200

Hopital de l'Archet 1, Nice

Cedex 13

Hopital Petie- SalpetriereDepartment d'Hematologie, Paris

04103

Universitatsklinikum Leipzig, Leipzig

00144

Ospedale Sant'Eugenio, Rome

00161

Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Rome

1081 HV

VU University Medical Center, Amsterdam

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

30-510

Malopolskie Centrum Medyczne S.C., Krakow

93-510

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

87-100

Specjalistyczny Szpital miejski im. Kopernika, Torun

04-141

Centralny Szpital Kliniczny MON, Warsaw

50-367

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

3000 - 075

Hospitais da Universidade de Coimbra, Coimbra

1649-035

Hospital de Dia de Hematologia, Lisbon

4200-072

Instituto Portugues Oncologia do Porto Francisco Gentil EPE, Porto

022328

Institutul Clinic Fundeni, Bucharest

030171

Spitalul Clinic Coltea, Bucharest

0002

Pretoria Academic Hospital, Pretoria

08916

Hospital Germans Trias I Pujol, Badalona

08003

Hospital del Mar, Barcelona

08035

Hospital Universitario Vall D hebron, Barcelona

221 85

Skane University Hospital, Lund

BH7 7DW

Royal Bournemouth General Hospital, Bournemouth

CB2 0QQ

Addenbrookes Hospital, Cambridge

G12 0YN

Gartnavel General Hospital, Glasgow

OX3 9DU

John Radcliffe Hospital, Headington

LS9 7TF

Saint James University Hospital, Leeds

L78XP

Royal Liverpool University Hospital, Liverpool

EC1A 7BE

St. Bartholomew's and The Royal London Hospital, London

SE1 9RT

Guy's and St. Thomas' Hospital, London

SE5 9RS

King's College Hospital, London

SW17 0QT

St George's Healthcare NHS Trust, London

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

S10 2JF

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust, Sheffield

SA28QA

Singleton Hospital, Southwest Wales Cancer Inst, Swansea

B71 4HJ

Sandwell Hospital, West Bromwich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT00774345 - A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy | Biotech Hunter | Biotech Hunter