Spots Global Cancer Trial Database for Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Official Title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Study ID: NCT00262782
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.
Detailed Description: OBJECTIVES: * Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only. OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms. * Arm I: Patients receive fludarabine. * Arm II: Patients undergo observation only. PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hanuschkrankenhaus, Vienna, , Austria
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik, Wien, , Austria
Klinikum St. Marien, Amberg, , Germany
Internistische Praxis - Arnstadt, Arnstadt, , Germany
Zentralklinikum Augsburg, Augsburg, , Germany
Kreiskrankenhaus Aurich, Aurich, , Germany
Regional Hospital Am Plattenwald, Bad Friedrichshall, , Germany
Regional Hospital Bad Hersfeld, Bad Hersfeld, , Germany
Arzt fuer Innere Medizin - Bad Reichenhall, Bad Reichenhall, , Germany
Humaine - Clinic, Bad Saarow, , Germany
Ermstalklinik Bad Urach, Bad Urach, , Germany
Internistische Praxis - Berlin, Berlin, , Germany
Internistische Gemeinschaftspraxis - Berlin, Berlin, , Germany
Haematologisch-Onkologische Schwerpunktpraxis, Berlin, , Germany
Internistische Praxis - Berlin, Berlin, , Germany
Internistische Gemeinschaftspraxis - Berlin, Berlin, , Germany
Charite - Campus Charite Mitte, Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Charite - Campus Virchow Klinikum, Berlin, , Germany
Gemeinschaftspraxis - Betzdorf, Betzdorf, , Germany
Praxis Dres. F.& G. Doering, Bremen, , Germany
Krankenhaus Burglengenfeld, Burglengenfeld, , Germany
Onkologische Schwerpunktpraxis, Cottbus, , Germany
Staedtisches Klinikum Dessau, Dessau, , Germany
Onkologische Gemeinschaftspraxis - Dresden, Dresden, , Germany
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
Michael Schaefers und Partner, Duisburg, , Germany
Internistische Gemeinschaftpraxis - Ehingen, Ehingen, , Germany
Onkologische Schwerpunktpraxis - Erding, Erding, , Germany
Internistische/Onkologische Praxis - Erfurt, Erfurt, , Germany
Onkologische Schwerpunkt Praxis, Erlangen, , Germany
St. Antonius Hospital, Eschweiler, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Staedtische Kliniken Esslingen, Esslingen, , Germany
Internistische Gemeinschaftspraxis - Forchheim, Forchheim, , Germany
Klinikum Garmisch - Partenkirchen, Garmisch-Partenkirchen, , Germany
Gemeinschaftspraxis - Germering, Germering, , Germany
Internistische Praxisgemeinschaft, Germering, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Onkologische Gemeinschaftspraxis - Gross-Gerau, Gross-Gerau, , Germany
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH, Hagen, , Germany
Allgemeines Krankenhaus Hagen, Hagen, , Germany
Internistische Praxis - Halle, Halle, , Germany
Internistische Gemeinschaftspraxis - Halle, Halle, , Germany
Martin Luther Universitaet, Halle, , Germany
Praxis fur Innere Medizin - Hamburg, Hamburg, , Germany
Allgemeines Krankenhaus St. Georg, Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover, Hannover, , Germany
Facharzt fuer Allgemeinmedizin - Hausham, Hausham, , Germany
Facharzt fuer Innere Medizin - Hechingen, Hechingen, , Germany
Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Medizinischen Klinik Dr. R. Schindlbeck, Herrsching, , Germany
Oncological Specialist Practice, Hildesheim, , Germany
Universitaetsklinikum des Saarlandes, Homburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein, , Germany
Praxis am Evangelischen Krankenhaus Bethanien, Iserlohn, , Germany
Internistische Gemeinschaftspraxis - Jena, Jena, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Staedt Klinikum Karlsruhe GGMBH, Karlsruhe, , Germany
Facharzt Fuer Jnnere Medizin, Karlsruhe, , Germany
St. Vincentius-Kliniken, Karlsruhe, , Germany
Internistische Gemeinschaftspraxis - Kassel, Kassel, , Germany
Staedtische Krankenhaus Kiel, Kiel, , Germany
Praxis Fuer Haematologie Internistische Onkologie, Koeln, , Germany
Medizinische Universitaetsklinik I at the University of Cologne, Koln, , Germany
Internistische Onkologische Praxis - Kronach, Kronach, , Germany
Internistische Praxis - Landshut, Landshut, , Germany
Onkologische Schwerpunktpraxis Leer, Leer, , Germany
Klinikum Lippe - Lemgo, Lemgo, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg, Magdeburg, , Germany
Gemeinschaftspraxis, Mannheim, , Germany
Philipps-Universitaet Marburg Klinikum, Marburg, , Germany
Internistische Gemeinschaftspraxis - Memmingen, Memmingen, , Germany
Klinikum Minden, Minden, , Germany
Haematologische Praxis - Moenchengladbach, Moenchengladbach, , Germany
Haematologisch-onkologische Gemeinschaftspraxis - Muenster, Muenster, , Germany
Klinikum Innenstadt, Munich, , Germany
Krankenhaus Muenchen Schwabing, Munich, , Germany
Hamatologische Schwerpunktpraxis, Munich, , Germany
Munich Oncologic Practice at Elisenhof, Munich, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany
Staedtisches Krankenhaus Muenchen - Harlaching, Munich, , Germany
Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau, Murnau, , Germany
Internistische Praxis - Neuenkirchen, Neuenkirchen, , Germany
Onkologische Schwerpunktpraxis Dr. Schmidt, Neunkirchen, , Germany
Praxis fuer Haematologie und Interne Onkologie, Norderstedt, , Germany
Sudharz-Krankenhaus Nordhausen gGmbH, Nordhausen, , Germany
Klinikum Nuernberg - Klinikum Nord, Nuernberg, , Germany
Internistische Gemeinschaftspraxis - Offenbach, Offenbach, , Germany
Hematologische Praxis, Oldenburg, , Germany
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck, Osnabrueck, , Germany
Municipal Hospital Complex, Pforzheim, , Germany
Hematologische Onkologische Praxis, Regensburg, , Germany
Jakobi Krankenhaus, Rheine, , Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock, Rostock, , Germany
Caritasklinik St. Theresia, Saarbrucken, , Germany
Schwerpunktpraxis Fuer Haematologie Und Onkologie, Saarbruecke, , Germany
Onkologische Schwerpunktpraxis - Schrobenhausen, Schrobenhausen, , Germany
Praxis - Schwenningen, Schwenningen, , Germany
St. Marien - Krankenhaus Siegen GMBH, Siegen, , Germany
Evang. Jung-Stilling Hospital, Siegen, , Germany
Praxisgemeinschaft - Stade, Stade, , Germany
Onkologische Schwerpunktpraxis - Straubing, Straubing, , Germany
Haematologische Praxis, Stuttgart, , Germany
Diakonie Klinikum Stuttgart, Stuttgart, , Germany
Onkologische Gemeinschaftspraxis - Trier, Trier, , Germany
Southwest German Cancer Center at Eberhard-Karls-University, Tuebingen, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
St. Marien Hospital, Vechta, , Germany
Gemeinschaftspraxis - Weiden, Weiden, , Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim, Weilheim, , Germany
Internistische Praxis - Wendlingen, Wendlingen, , Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Kliniken St. Antonius, Wuppertal 2, , Germany
Hamatologisch - Onkologische Praxis Wurzburg, Wurzburg, , Germany
Contact Details
Name: Michael Hallek, MD
Affiliation: Medizinische Universitaetsklinik I at the University of Cologne
Role: STUDY_CHAIR
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