A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

PHASE3TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

April 1, 2010

Primary Completion Date

March 1, 2011

Study Completion Date

March 1, 2011

Conditions
Mantle Cell LymphomaNon-Hodgkin's Lymphoma
Interventions
DRUG

Lenalidomide

15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

OTHER

Placebo

Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Trial Locations (92)

10021

Weill Cornell Medical College/New York Presbyterian Hospital, New York

10034

Fakultni Nemocnice Kralovske Vinohrady, Prague

10126

Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette), Torino

11042

Arena Oncology Associates, Lake Success

12808

Vseobecna Fakultni Nemocnice, Prague

13210

SUNY Upstate Medical University, Syracuse

15121

Az. Osp. SS.Antonio e Biagio SC Ematologia, Alessandria

16132

"Azienda Ospedaliera Universitaria San Martino", Genova

19111

Fox Chase Cancer Center, Philadelphia

20099

Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation, Hamburg

20132

Fondazione San Raffaele del Monte Tabor I.R.C.C.S., Milan

20162

A,O Ospedale Niguarda Ca Granda Dept Hematology, Milan

22908

University of Virginia Health Systems, Charlottesville

27100

Policlinico San Matteo - Dip. Di Ematologia, Pavia

28100

"Università del Piemonte Orientale Amedeo Avogadro", Novara

29600

Hospital Costa del Sol, Oncology, Marbella (Málaga)

31008

Clinica Universitaria de Navarra, Hematology, Pamplona

31059

Hôpital Purpan CHU de Toulouse, Toulouse

33100

Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria, Udine

33604

CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie, Pessac

34295

CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale, Montpellier

35033

Hôpital Pontchaillou Hématologie Clinique, Rennes

37007

Hospital Clínico Universitario de Salamanca, Salamanca

37044

Hôpital Bretonneau - CHU Tours, Tours

37099

UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie, Göttingen

38700

Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie, La Tronche

39008

Hospital Marques de Valdecilla, Santander

39100

Ospedale Regionale di Bolzano - Divisione di Ematologia, Bolzano

44093

CHRU - Hotel Dieu, Nantes

45122

Universitätsklinikum Essen Zentrum für Innere Medizin, Essen

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

49000

CHU Hôpital Hotel Dieu, Angers

49100

Davidoff Cancer Center The Institute of Hematology, Petah Tikva

50139

Hematology Dept, Azienda Ospedaliero Universitaria Careggi, Florence

51092

CHU de Reims, Hôpital Robert Debré, Hématologie Clinique, Reims

53439

Dolnoslaskie Centrum Transplantacji Komórkowych, Wroclaw

54511

CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne, Vandœuvre-lès-Nancy

57105

Avera Cancer Institute, Sioux Falls

59037

CHRU - Hôpital Claude Huriez, Lille

60612

Rush University Medical Center, Chicago

63003

CHU ESTAING, Service d'Hématologie, Clermont-Ferrand

68506

Nebraska Hematology-Oncology, PC, Lincoln

69495

Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie, Pierre-Bénite

71013

IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia, S.Giovanni Rotondo (FG)

72076

Universitaetsklinikum Tuebingen, Tübingen

73039

Ospedale Cardinale G. Panico - Ematologia e Immunoematologia, Tricase

75475

Hôpital Saint-Louis, Paris

76038

Centre Henri Becquerel, Rouen

76135

Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe, Karlsruhe

77520

Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika, Olomouc

79106

Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie, Freiburg im Breisgau

80054

CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique, Amiens

80131

"Istituto Nazionale Tumori Fondazione G. Pascale - Oncoematologia", Napoli

80218

Rocky Mountain Cancer Center, Denver

81377

Klinikum der Universität München - Großhadern, Medizinische Klinik III, München

84101

Soroka Medical Center The Institute of Hematology, Beersheba

85000

CHD Les Oudairies, Service d'Oncologie Hématologie, La Roche-sur-Yon

86000

CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire, Poitiers

89100

Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia, Reggio Calabria

92123

Sharp Healthcare Oncology Associates of San Diego, San Diego

93510

Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lodz

94010

Hôpital Henri Mondor Unité Hémopathies Lymphoides, Créteil

97213

Providence Cancer Center, Indianapolis

98158

Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia, Messina

115478

Russian Oncological Research Centre, Moscow

191024

Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency, Saint Petersburg

197022

State Educational Institution of High Professional Education, Saint Petersburg

197341

Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies, Saint Petersburg

400138

"State Healthcare Institution Volgograd Regional Clinical OncologyDispensary #1", Volgograd

420029

Republican Clinical Oncological Dispensary, Kazan'

614600

Perm Regional Clinical Hospital, Perm

620102

Sverdlovsk Regional Clinical Hospital - Volgogradskaya, Yekaterinburg

07601

Hackensack University Medical Center, Hackensack

500 05

Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie, Hradec Králové

Unknown

Clinic of Oncology Faculty Hospital Motol, Prague

Hospital de Madrid Norte- Sanchinarro, Madrid

C. H. de Orense, Ourense

00168

Università Cattolica del Sacro Cuore Policlinico A. Gemelli, Roma

30-510

Małopolskie Centrum Medyczne, Krakow

300-075

Serviço de Hematologia, Coimbra

1099-023

Instituto Português de Oncologia (IPO) de Lisboa, Lisbon

4200-072

Instituto Português de Oncologia (IPO) do Porto, Porto

00918

Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico, San Juan

08035

Hospital Universitario Vall d´Hebrón Hematology Department, Barcelona

CT1 3NG

Kent and Canterbury Hospital, Canterbury, Kent

TQ2 7AA

Torbay Hospital, County of Devon

EX2 5DW

Royal Devon & Exeter Hospital, Exeter

G12 OXL

Beatson West of Scotland Cancer Centre, Glasgow

EC1M 6BQ

Barts & The London NHS Trust Medical Oncology, London

PL6 8DH

Derriford Hospital, Plymouth

SP2 8BJ

Salisbury NHS Foundation Trust, Haematology, Salisbury

WA9 3DA

St Helens Hospital, Lilac Lower Ground, St Helens

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY