Spots Global Cancer Trial Database for Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL
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Trial Identification
Brief Title: Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL
Official Title: Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study ID: NCT01449344
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.
Detailed Description: This study is a prospective, randomized, multicenter, open-label phase III clinical trial to compare the efficacy and safety of Bortezomib in combination with Rituximab, high-dose Ara-C and dexamethasone (R-HAD) to R-HAD alone in patients with relapsed or refractory MCL after or not eligible for myeloablative treatment. The primary endpoint is time to treatment failure (TTF). Secondary endpoints are the complete response (CR) rate, the overall response (CR,PR) rate, the progression-free survival (PFS), the progression free survival of responders, the time to next lymphoma treatment, overall survival (OS), safety and tolerability of Rituximab, high-dose Ara-C and dexamethasone alone or in combination with Bortezomib. Study arms will be compared to each other to evaluate the impact of additional Bortezomib. Study arms will also be compared to historical controls.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CH Victor Dupouy, Service hématologie, Argenteuil Cedex, , France
Centre Hospitalier de la côte Basque, Service hématologie, Bayonne, , France
CH de Blois, Service hématologie, Blois, , France
Institut Bergonie, Service Hématologie, Bordeaux, , France
CH Sud Francilien de Corbeil, Service hématologie, Corbeil Essonnes, , France
Hôpital Henri Mondor, Service hématologie, Créteil, , France
Hôpital Albert Michallon, Service hématologie, Grenoble, , France
CH Mulhouse, Service hématologie, Le Mans, , France
Clinique Victor Hugo, Service hématologie, Le Mans, , France
CH du Mans, Service hématologie, Le Mans, , France
CHU de Nice, Service hématologie, Nice, , France
CHU Necker, Service d'hématologie - adulte, Paris, , France
Hôpital Haut Lévêque, Service hématologie, Pessac, , France
CHU Lyon Sud, Service hématologie, Pierre Benite, , France
Hôpital Jean Bernard, Service hématologie, Poitiers, , France
CH René Dubos, Service hématologie, Pontoise, , France
CHU Robert Debré, Service hématologie, Reims, , France
Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan, Tours, , France
CHU Brabois, Service hématologie, Vandoeuvre les Nancy, , France
CH de Bretagne Atlantique, Service Hématologie, Vannes, , France
Institut Gustave ROUSSY, Villejuif, , France
Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin, Altötting, , Germany
Klinikum St. Marien, Med. Klinik II, Amberg, , Germany
Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie, Berlin, , Germany
Knappschaftskrankenhaus, Onkologische Ambulanz, Bottrop, , Germany
Praxis für Hämatologie/Onkologie,, Burgwedel, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
Universitätsklinik Essen, Klinik für Hämatologie, Essen, , Germany
Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie, Frankfurt am Main, , Germany
Ernst-Moritz-Arndt-Universität, Hämatologie/Onkologie, Greifswald, , Germany
Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital, Hagen, , Germany
Asklepios Klinik St. Georg, Abteilung Hämatologie, Hamburg, , Germany
St.-Marien-Hopsital Gem. GmbH, Hamm, , Germany
Universitätsklinik des Saarlandes, Homburg/Saar, , Germany
Westpfalz-Klinikum GmbH, I. Medizinische Klinik, Kaiserslautern, , Germany
UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK, Kiel, , Germany
Klinikum der Universität zu Köln, Klinik I f. Innere Medizin, Köln, , Germany
Praxis Dr. Vehling-Kaiser, Landshut, , Germany
Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie, Magdeburg, , Germany
Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie, Marburg, , Germany
Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin, Mutlangen, , Germany
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus), Mönchengladbach, , Germany
LMU München - Klinikum Großhadern Medizinische Klinik III, München, , Germany
Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie, Nürnberg, , Germany
Schlossberg Klinik, Oberstaufen Internistische Onkologie, Oberstaufen, , Germany
Diakonie Klinikum Jung Stilling Krankenhaus, Siegen, , Germany
Diakonieklinikum Stuttgart, Medizinische Klinik II, Stuttgart, , Germany
Robert-Bosch-Krankenhaus, Hämatologie/Onkologie, Stuttgart, , Germany
Mutterhaus der Borromäerinnen, Medizinische Abteilung, Trier, , Germany
Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung, Trier, , Germany
Universitätsklinikum Ulm, Innere Medizin III, Ulm, , Germany
Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin, Wernigerode, , Germany
Ammerland-Klinik GmbH, Klinik für innere Medizin, Westerstede, , Germany
Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III, Zwickau, , Germany
Contact Details
Name: Martin Dreyling, MD
Affiliation: Klinikum der Universität München, Grosshadern
Role: PRINCIPAL_INVESTIGATOR
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