Spots Global Cancer Trial Database for Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia
Official Title: Multicentre Phase II Trial of Bendamustine in Combination With Rituximab for Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)
Study ID: NCT00274989
Conditions
Study Description
Brief Summary: CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL.
Detailed Description: Conventional chemotherapy and also high dose chemotherapy with autologous stem cell transplantation are not curative treatment options in B-CLL; nearly all patients will eventually relapse. Also monoclonal antibodies are not curative for B-CLL patients in monotherapy, their impact on survival in combination with conventional chemotherapy is currently validated. In addition, there is no standard combination therapy for patients with relapsed CLL. Therefore there is an urgent medical need to identify new strategies. The combination of rituximab (monoclonal antibody) and bendamustine (chemotherapy) has shown encouraging activity in patients with relapsed/refractory NHL or mantle cell lymphoma. In vitro studies have been used to investigate the effects of bendamustine and rituximab on programmed cell death (apoptosis) and have shown synergistic effects of both drugs. The mechanisms of action of these two active drugs may provide a treatment with good therapeutic potential in CLL. However, though bendamustine has been used for over 30 years there is still a need to define a standard regimen for the use of bendamustine in combination with monoclonal antibodies (mAb) especially in the treatment of CLL.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Internistische Praxis - Arnstadt, Arnstadt, , Germany
Klinikum Augsburg, Augsburg, , Germany
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
Internistische Gemeinschaftspraxis - Berlin, Berlin, , Germany
Charite - Campus Charite Mitte, Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Charite University Hospital - Campus Virchow Klinikum, Berlin, , Germany
Augusta-Kranken-Anstalt gGmbH, Bochum, , Germany
Marienhospital Bottrop gGmbH, Bottrop, , Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH, Bremen, , Germany
Medizinische Universitaetsklinik I at the University of Cologne, Cologne, , Germany
Klinikum Darmstadt, Darmstadt, , Germany
Krankenhaus Benrath, Dusseldorf, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Staedtische Kliniken Esslingen, Esslingen, , Germany
Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), , Germany
Klinikum Garmisch - Partenkirchen GmbH, Garmisch-Partenkirchen, , Germany
Internistische Praxisgemeinschaft, Germering, , Germany
Universitaetsklinikum Goettingen, Goettingen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Allgemeines Krankenhaus Hagen, Hagen, , Germany
Praxis fur Innere Medizin - Hamburg, Hamburg, , Germany
Hamatologische/Onkologische - Hamburg, Hamburg, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Evangelische Krankenhaus Hamm, Hamm, , Germany
Universitaetsklinikum des Saarlandes, Homburg, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
University Hospital Schleswig-Holstein - Kiel Campus, Kiel, , Germany
Onkologische Schwerpunktpraxis - Leer, Leer, , Germany
Klinikum Lippe - Lemgo, Lemgo, , Germany
Gemeinschaftspraxis - Ludwigshafen, Ludwigshafen, , Germany
Kreiskrankenhaus Luedenscheid, Luedenscheid, , Germany
Staedtisches Klinikum Magdeburg, Magdeburg, , Germany
Krankenhaus Maria Hilf GmbH, Moenchengladbach, , Germany
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster, Muenster, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany
Onkologische Schwerpunktpraxis Dr. Schmidt, Neunkirchen, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Paracelsus Karankenhaus Ruit, Ostfildern, , Germany
Gemeinschaftspraxis - Pinneberg, Pinnebeg, , Germany
Klinikum Ernst Von Bergmann, Potsdam, , Germany
Scherpunktpraxis fur Hematologie und Onkologie, Regensburg, , Germany
Klinikum der Universitaet Regensburg, Regensburg, , Germany
Krankenhaus Barmherzige Brueder Regensburg, Regensburg, , Germany
Internistische Praxis Dres. Hempel und Hochdorfer, Rehling, , Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock, Rostock, , Germany
Caritasklinik St. Theresia, Saarbrucken, , Germany
Schwerpunktpraxis fur Hamatologie und Onkologie, Siegburg, , Germany
St. Marien - Krankenhaus Siegen GMBH, Siegen, , Germany
Hanse-Klinikum Stralsund - Krankenhaus West, Stralsund, , Germany
Haematologische Praxis, Stuttgart, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen, Trier, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm, , Germany
St. Marienhospital - Vechta, Vechta, , Germany
Heinrich-Braun-Krankenhaus Zwickau, Zwickau, , Germany
Contact Details
Name: Clemens M. Wendtner
Affiliation: Medizinische Universitaetsklinik I at the University of Cologne
Role: STUDY_CHAIR
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