Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
- Registration Number
- NCT00262782
- Lead Sponsor
- German CLL Study Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 877
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine Fludarabine -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (115)
Internistische Praxis - Neuenkirchen
🇩🇪Neuenkirchen, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
Internistische Praxis - Arnstadt
🇩🇪Arnstadt, Germany
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
🇦🇹Wien, Austria
Kreiskrankenhaus Aurich
🇩🇪Aurich, Germany
Regional Hospital Am Plattenwald
🇩🇪Bad Friedrichshall, Germany
Arzt fuer Innere Medizin - Bad Reichenhall
🇩🇪Bad Reichenhall, Germany
Internistische Praxis - Berlin
🇩🇪Berlin, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Charite - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Onkologische Gemeinschaftspraxis - Dresden
🇩🇪Dresden, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Gemeinschaftspraxis - Betzdorf
🇩🇪Betzdorf, Germany
Onkologische Schwerpunktpraxis
🇩🇪Cottbus, Germany
Universitaetsklinik Duesseldorf
🇩🇪Duesseldorf, Germany
Michael Schaefers und Partner
🇩🇪Duisburg, Germany
Onkologische Gemeinschaftspraxis - Gross-Gerau
🇩🇪Gross-Gerau, Germany
Internistische/Onkologische Praxis - Erfurt
🇩🇪Erfurt, Germany
Internistische Gemeinschaftpraxis - Ehingen
🇩🇪Ehingen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Internistische Praxis - Halle
🇩🇪Halle, Germany
Internistische Gemeinschaftspraxis - Forchheim
🇩🇪Forchheim, Germany
Praxis fur Innere Medizin - Hamburg
🇩🇪Hamburg, Germany
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH
🇩🇪Hagen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Allgemeines Krankenhaus St. Georg
🇩🇪Hamburg, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
🇩🇪Hannover, Germany
Facharzt fuer Innere Medizin - Hechingen
🇩🇪Hechingen, Germany
Onkologische Schwerpunktpraxis Heidelberg
🇩🇪Heidelberg, Germany
Facharzt fuer Allgemeinmedizin - Hausham
🇩🇪Hausham, Germany
Medizinischen Klinik Dr. R. Schindlbeck
🇩🇪Herrsching, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Staedt Klinikum Karlsruhe GGMBH
🇩🇪Karlsruhe, Germany
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
Praxis am Evangelischen Krankenhaus Bethanien
🇩🇪Iserlohn, Germany
Internistische Gemeinschaftspraxis - Jena
🇩🇪Jena, Germany
Staedtische Krankenhaus Kiel
🇩🇪Kiel, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Koeln, Germany
Facharzt Fuer Jnnere Medizin
🇩🇪Karlsruhe, Germany
Internistische Praxis - Landshut
🇩🇪Landshut, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Gemeinschaftspraxis
🇩🇪Mannheim, Germany
Onkologische Schwerpunktpraxis Leer
🇩🇪Leer, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Internistische Gemeinschaftspraxis - Memmingen
🇩🇪Memmingen, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Haematologische Praxis - Moenchengladbach
🇩🇪Moenchengladbach, Germany
Philipps-Universitaet Marburg Klinikum
🇩🇪Marburg, Germany
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
🇩🇪Muenster, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
🇩🇪Munich, Germany
Hamatologische Schwerpunktpraxis
🇩🇪Munich, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Sudharz-Krankenhaus Nordhausen gGmbH
🇩🇪Nordhausen, Germany
Hematologische Praxis
🇩🇪Oldenburg, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Hematologische Onkologische Praxis
🇩🇪Regensburg, Germany
Municipal Hospital Complex
🇩🇪Pforzheim, Germany
Jakobi Krankenhaus
🇩🇪Rheine, Germany
Gemeinschaftspraxis - Weiden
🇩🇪Weiden, Germany
Onkologische Schwerpunktpraxis - Schrobenhausen
🇩🇪Schrobenhausen, Germany
Evang. Jung-Stilling Hospital
🇩🇪Siegen, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Praxisgemeinschaft - Stade
🇩🇪Stade, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Kliniken St. Antonius
🇩🇪Wuppertal 2, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Internistische Praxis - Wendlingen
🇩🇪Wendlingen, Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
🇩🇪Weilheim, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Regional Hospital Bad Hersfeld
🇩🇪Bad Hersfeld, Germany
Praxis Dres. F.& G. Doering
🇩🇪Bremen, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Haematologisch-Onkologische Schwerpunktpraxis
🇩🇪Berlin, Germany
Ermstalklinik Bad Urach
🇩🇪Bad Urach, Germany
Krankenhaus Burglengenfeld
🇩🇪Burglengenfeld, Germany
Staedtisches Klinikum Dessau
🇩🇪Dessau, Germany
Onkologische Schwerpunktpraxis - Erding
🇩🇪Erding, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Gemeinschaftspraxis - Germering
🇩🇪Germering, Germany
Klinikum Garmisch - Partenkirchen
🇩🇪Garmisch-Partenkirchen, Germany
Internistische Praxisgemeinschaft
🇩🇪Germering, Germany
Martin Luther Universitaet
🇩🇪Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Oncological Specialist Practice
🇩🇪Hildesheim, Germany
Haematologische Praxis
🇩🇪Stuttgart, Germany
St. Vincentius-Kliniken
🇩🇪Karlsruhe, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Koln, Germany
Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau
🇩🇪Murnau, Germany
Klinikum Minden
🇩🇪Minden, Germany
Klinikum Innenstadt
🇩🇪Munich, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munich, Germany
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
🇩🇪Osnabrueck, Germany
Internistische Gemeinschaftspraxis - Offenbach
🇩🇪Offenbach, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Schwerpunktpraxis Fuer Haematologie Und Onkologie
🇩🇪Saarbruecke, Germany
Praxis - Schwenningen
🇩🇪Schwenningen, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
St. Marien Hospital
🇩🇪Vechta, Germany
Onkologische Gemeinschaftspraxis - Trier
🇩🇪Trier, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Onkologische Schwerpunktpraxis - Straubing
🇩🇪Straubing, Germany