A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

June 28, 2018

Study Completion Date

October 9, 2018

Conditions
Mantle Cell LymphomaLymphoma, Mantle-Cell
Interventions
DRUG

Lenalidomide

"For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.~For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but \< 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity."

DRUG

Investigators choice single agent

Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine

Trial Locations (97)

1090

UZ Brussels, Brussels

2100

Rigshospitalet Department of Haematology L4042, Copenhagen

2730

Herlev Hospital, Herlev

5530

Cliniques Universitaires UCL de Mont-Godine, Yvoir

7513

Medisch Spectrum Twente, Enshede

8011

Isala Klinieken, Zwolle

8035

Hospital Universitario Vall D Hebron, Barcelona

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

12462

Attikon General University Hospital of Athens, Athens

12808

Charles University General Hospital, Prague

13273

Institut Paoli-Calmettes, Marseille

16132

Azienda Ospedaliera Universitaria San Martino, Genova

20141

Istituto Europeo di Oncologia - IEO, Milan

20932

San Raffaele Scientific Institute, Milan

22185

Lund University Hosptial, Lund

26500

University of Patras, Pátrai

27100

I.R.C.C.S. Policlinico San Matteo, Pavia

28006

Hospital de La Princesa, Madrid

28046

Hospital La Paz, Madrid

29603

Hospital Costa del Sol, Marbella

31008

Clinica Universitaria de Navarra, Pamplona

33300

Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie, Bordeaux

33604

CHRU - Hopital du Haut Leveque, Pessac

34295

CHU Montpellier - Hôpital Saint Eloi, Montpellier

35033

CHU Rennes Hematology, Rennes

35254

Rambam Medical Center, Haifa

37099

UKG Universitatsklinikum Gottingen, Göttingen

38043

CHU Hopital Michallon, Grenoble

39100

Ospedale Regionale di Bolzano, Bolzano

40138

A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna

44093

CHRU - Hotel Dieu, Nantes

45122

Universitatsklinikum Essen, Essen

48129

Universitatsklinik Munster, Münster

49100

Rabin Medical Center, Petah Tikva

50937

Uniklinik Koln, Cologne

52621

Sheba Medical Center, Tel Litwinsky

54511

CHRU Hopitaux de Brabois, Vandœuvre-lès-Nancy

56126

Ospedale S. Chiara, Pisa

59037

CHRU-Hopital Claude Huriez, Lille

63003

Hotel Dieu, Clermont-Ferrand

66421

Universitatsklinikum des Saarlandes, Homburg-Saar

67091

Hopital civil, Strasbourg

67098

CHRU Hôpital de Hautepierre, Strasbourg

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

A.O. Policlinico - Università di Bari, Bari

71013

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

72000

Clinique Victor Hugo, Le Mans

73100

Ematologia ed Immunologia, Lecce

75010

Hopital Saint-Louis, Paris

75185

University Hospital Uppsala, Uppsala

76135

Stadtisches Klinikum Karlsruhe, Karlsruhe

79038

Centre Henri Becquerel, Rouen

79106

Universitaetsklinikum FreiburgInnere Med.1, Haematologie, Freiburg im Breisgau

85025

Centre Hospitalier Departemental Les Oudrairies, La Roche-sur-Yon

85028

Reference Cancer Center of Basilicata, Rionero in Vulture

87042

CHU Dupuytren, Limoges

89081

University of Ulm, Ulm

89100

"Azienda Ospedaliera Bianchi-Melacrino-Morelli", Reggio Calabria

90146

Az. Osp. Vincenzo Cervello, Palermo

91120

Hadassah University Hospital, Jerusalem

95124

Ospedale Ferrarotto, Catania

115447

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

191024

St. Petersburg Research Institute of Hematology and Blood Transfusion, Saint Petersburg

196022

St. Petersburg Pavlov State Medical University, Saint Petersburg

197341

Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, Saint Petersburg

249036

Medical Radiology Research Centre RAMS, Obninsk

344937

Scientific Research Institute of OncologySoft Tissue Department, Rostov-on-Don

400138

Volgograd Regional Clinical Oncology Dispensary 1, Volgograd

420029

Republic Clinical Oncology Dispensary, Kazan'

603126

Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko, Nizhny Novgorod

614066

Perm Territorial Oncology Dispensary, Perm

620102

Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg

630087

Novosibirsk State Regional Clinical Hospital, Novosibirsk

625 00

Teaching Hospital BrnoHemato-oncology Dept, Brno

500 05

University Hospital2.Dep. of Int.med. hematology, Hradec Králové

06050

Centre Antoine Lacassagne Oncologie medicale et Hematologie, Nice

D-20099

Asklepios Klinik St. Georg, Hamburg

06100

Az. Osp di Perugia, Perugia

3818 ES

Meander Medisch Centrum, Amersfoort

30-510

Malopolskie Centrum medyczne s.c., Krakow

31-501

Uniwersytet Jagiellonski Collegium Medicum, Krakow

93-510

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

02-781

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie, Warsaw

50-367

Nowotworww Krwi i Transplantacji Szpiku, Wroclaw

53-439

Dolnoslaskie Centrum Transplantacji Komorkowych, Wroclaw

410 028

Saratov Medical University Chair of Professional Pathology and Haematology, Saratov

BH7 7DW

Royal Bournemouth Hosp, Bournemouth

CB2 0QQ

Addenbrookes Hospital, Cambridge

L7 8XP

Royal Liverpool University Hospital, Liverpool

M20 4BX

Christie Hospital, Manchester

NE1 4LP

Newcastle Hospital Foundation Trust, Newcastle upon Tyne

OX3 7LJ

John Radcliffe Hospital, Oxford

PL6 8DH

Derriford Hospital, Plymouth

SO16 6YD

Southampton General Hospital, Southampton

WV10 0QP

The Royal Wolverhampton Hospital NHS Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY