Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00262795
- Lead Sponsor
- German CLL Study Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
Primary
* Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
* Compare the duration of remission in patients treated with these regimens.
Secondary
* Compare the incidence of toxicity, especially infections, in patients treated with these regimens.
* Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.
* Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLB Chlorambucil Chlorambucil F Fludarabine Fludarabine
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
Onkologische Schwerpunktpraxis
🇩🇪Cottbus, Germany
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Saint Josef - Hospital Bochum
🇩🇪Bochum, Germany
Internistische Praxis - Halle
🇩🇪Halle, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Krankenhaus Maria-Hilf Krefeld
🇩🇪Krefeld, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
🇩🇪Muenster, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Regional Hospital Munchberg
🇩🇪Munchber, Germany
Internistische Gemeinschaftspraxis - Saarbruecken
🇩🇪Saarbruecken, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
🇩🇪Munich, Germany
Internistische Gemeinschaftspraxis - Offenbach
🇩🇪Offenbach, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Kliniken Landkreis Sigmaringen GMBH
🇩🇪Sigmaringen, Germany
Internistische Gemeinschaftspraxis - Stuttgart
🇩🇪Stuttgart, Germany
Kreiskrankenhaus Erding
🇩🇪Erding, Germany
Marienhospital Stuttgart
🇩🇪Stuttgart, Germany
Haematologische Praxis
🇩🇪Stuttgart, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
St. Marien Hospital
🇩🇪Vechta, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Essen, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
🇩🇪Hannover, Germany
Gemeinschaftspraxis
🇩🇪Worms, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany
Schwerpunktpraxis Fuer Haematologie Und Onkologie
🇩🇪Saarbruecke, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Medizinischen Klinik Dr. R. Schindlbeck
🇩🇪Herrsching, Germany
Staedt Klinikum Karlsruhe GGMBH
🇩🇪Karlsruhe, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
Klinikum Innenstadt
🇩🇪Munich, Germany
Staedtische Krankenhaus Kiel
🇩🇪Kiel, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munich, Germany
Internistische Praxis - Ludwigsburg
🇩🇪Ludwigsburg, Germany
Kreiskrankenhaus Luedenscheid
🇩🇪Luedenscheid, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Munchen
🇩🇪Munchen, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Charite - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Internistische Schwerpunktpraxis
🇩🇪Russelsheim, Germany
Klinikum Ernst Von Bergmann
🇩🇪Postdam, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Onkologische Gemeinschaftspraxis - Trier
🇩🇪Trier, Germany
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Onkologisches Versorgungszentrum Friedrichshain
🇩🇪Berlin, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
🇩🇪Bayreuth, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Praxis Dres. F.& G. Doering
🇩🇪Bremen, Germany
Krankenhaus Benrath
🇩🇪Dusseldorf, Germany
Onkologische Gemeinschaftspraxis - Dresden
🇩🇪Dresden, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Internistische/Onkologische Praxis - Erfurt
🇩🇪Erfurt, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera
🇩🇪Gera, Germany
Gemeinschaftspraxis - Freiburg
🇩🇪Freiburg, Germany
Internistische Praxisgemeinschaft
🇩🇪Germering, Germany
Klinikum Garmisch - Partenkirchen
🇩🇪Garmisch-Partenkirchen, Germany
Internistische Praxis - Gerlingen
🇩🇪Gerlingen, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Internistische Praxis - Landshut
🇩🇪Landshut, Germany
Hamatologische Schwerpunktpraxis
🇩🇪Munich, Germany
Praxisklinik fuer Innere Medizin - Nuernberg
🇩🇪Nuernberg, Germany
Internistische Gemeinschaftspraxis - Oberstaufen
🇩🇪Oberstaufen, Germany
Haematologische/Onkologische Schwerpunktpraxis - Rostock
🇩🇪Rostock, Germany
Kliniken St. Antonius
🇩🇪Wuppertal 2, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Oncological Specialist Practice
🇩🇪Hildesheim, Germany
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
🇩🇪Gustrow, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Eichsfeld Klinikum gGmbH
🇩🇪Heiligenstadt, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany