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
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