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

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Trial Identification

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

Official Title: A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Study ID: NCT00875667

Study Description

Brief Summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

Detailed Description: This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma. The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UZ Brussels, Brussel, , Belgium

UZ Gent, Gent, , Belgium

AZ Groeninge, Kortrijk, , Belgium

Cliniques Universitaires UCL de Mont-Godine, Yvoir, , Belgium

Teaching Hospital BrnoHemato-oncology Dept, Brno, , Czechia

University Hospital2.Dep. of Int.med. hematology, Hradec Kralove, , Czechia

Charles University General Hospital, Prague, , Czechia

Rigshospitalet Department of Haematology L4042, Copenhagen, , Denmark

Herlev Hospital, Herlev, , Denmark

Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie, Bordeaux, , France

Hotel Dieu, Clermont Ferrand, , France

CHU Hopital Michallon, Grenoble cedex 09, , France

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

Clinique Victor Hugo, Le Mans, , France

CHRU-Hopital Claude Huriez, Lille, , France

CHU Dupuytren, Limoges Cedex 1, , France

Centre Leon Berard, Lyon, , France

Institut Paoli-Calmettes, Marseille, , France

CHU Montpellier - Hôpital Saint Eloi, Montpellier CEDEX 5, , France

CHRU - Hotel Dieu, Nantes Cedex 1, , France

Centre Antoine Lacassagne Oncologie medicale et Hematologie, Nice cedex 1, , France

Hopital Saint-Louis, Paris, , France

CHRU - Hopital du Haut Leveque, Pessac, , France

Centre Hospitalier Lyon Sud, Pierre-Bénite cedex, , France

CHU Rennes Hematology, Rennes, , France

Centre Henri Becquerel, Rouen Cedex, , France

Hopital civil, Strasbourg, , France

CHRU Hôpital de Hautepierre, Strasbourg, , France

CHRU Hopitaux de Brabois, Vandoeuvre, , France

Universitatsklinikum Essen, Essen, , Germany

Universitaetsklinikum FreiburgInnere Med.1, Haematologie, Freiburg, , Germany

UKG Universitatsklinikum Gottingen, Göttingen, , Germany

Asklepios Klinik St. Georg, Hamburg, , Germany

Universitatsklinikum des Saarlandes, Homburg-Saar, , Germany

Stadtisches Klinikum Karlsruhe, Karlsruhe, , Germany

Uniklinik Koln, Koeln, , Germany

Universitatsklinik Munster, Muenster, , Germany

University of Ulm, Ulm, , Germany

Attikon General University Hospital of Athens, Athens, , Greece

University of Patras, Patras, , Greece

Rambam Medical Center, Haifa, , Israel

Hadassah University Hospital, Jerusalem, , Israel

Rabin Medical Center, Petach-Tikva, , Israel

Sheba Medical Center, Tel Hashomer, , Israel

A.O. Policlinico - Università di Bari, Bari, , Italy

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

Ospedale Regionale di Bolzano, Bolzano, , Italy

Ospedale Ferrarotto, Catania, , Italy

Azienda Ospedaliera Universitaria San Martino, Genova, , Italy

Ematologia ed Immunologia, Lecce, , Italy

Istituto Europeo di Oncologia - IEO, Milano, , Italy

San Raffaele Scientific Institute, Milano, , Italy

Az. Osp. Vincenzo Cervello, Palermo, , Italy

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

Az. Osp di Perugia, Perugia, , Italy

Ospedale S. Chiara, Pisa, , Italy

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

Reference Cancer Center of Basilicata, Rionero in Vulture, , Italy

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

Meander Medisch Centrum, Amersfoort, , Netherlands

Medisch Spectrum Twente, Enshede, , Netherlands

Isala Klinieken, Zwolle, , Netherlands

Uniwersytet Jagiellonski Collegium Medicum, Krakow, , Poland

Malopolskie Centrum medyczne s.c., Kraków, , Poland

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

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

Nowotworww Krwi i Transplantacji Szpiku, Wroclaw, , Poland

Dolnoslaskie Centrum Transplantacji Komorkowych, Wroclaw, , Poland

Sverdlovsk Regional Clinical Hospital 1, Ekaterinburg, , Russian Federation

Republic Clinical Oncology Dispensary, Kazan, , Russian Federation

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

Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko, Nizhniy Novgorod, , Russian Federation

Novosibirsk State Regional Clinical Hospital, Novosibirsk, , Russian Federation

Medical Radiology Research Centre RAMS, Obninsk, , Russian Federation

Perm Territorial Oncology Dispensary, Perm, , Russian Federation

Scientific Research Institute of OncologySoft Tissue Department, Rostov-na-Donu, , Russian Federation

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

St. Petersburg Pavlov State Medical University, Saint-Petersburg, , Russian Federation

Saratov Medical University Chair of Professional Pathology and Haematology, Saratov, , Russian Federation

Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, St. Petersburg, , Russian Federation

Volgograd Regional Clinical Oncology Dispensary 1, Volgograd, , Russian Federation

Hospital Universitario Vall D Hebron, Barcelona, , Spain

Hospital de La Princesa, Madrid, , Spain

Hospital La Paz, Madrid, , Spain

Hospital Costa del Sol, Marbella, , Spain

Clinica Universitaria de Navarra, Pamplona, , Spain

Lund University Hosptial, Lund, , Sweden

University Hospital Uppsala, Uppsala, , Sweden

Royal Bournemouth Hosp, Bournemouth, , United Kingdom

Addenbrookes Hospital, Cambridge, , United Kingdom

Royal Liverpool University Hospital, Liverpool, , United Kingdom

Christie Hospital, Manchester, , United Kingdom

Newcastle Hospital Foundation Trust, Newcastle Upon Tyne, , United Kingdom

John Radcliffe Hospital, Oxford, , United Kingdom

Derriford Hospital, Plymouth, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

The Royal Wolverhampton Hospital NHS Trust, Wolverhampton, , United Kingdom

Contact Details

Name: Marek Trneny, MD/PhD/Prof

Affiliation: Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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