Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00276848
- Lead Sponsor
- German CLL Study Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, 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 giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
Primary
* Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.
Secondary
* Compare the incidence of side effects and quality of life of patients treated with these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms
* Arm I: Patients receive fludarabine IV on days 1-5.
* Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine plus Cyclophosphamide Fludarabine plus Cyclophosphamide - Fludarabine Fludarabine -
- Primary Outcome Measures
Name Time Method Progression-free survival 18 Month after end of treatment of the last patient date of randomization until progression of disease or death of any cause
Overall survival 18 Month after end of treatment of the last patient Date of randomization until date of death
Duration of remission 18 Month after end of treatment of the last patient Clinical response was defined according to the guidelines of the NCI-sponsored workshop
- Secondary Outcome Measures
Name Time Method Incidence of side effects up to 28 days after the last dose of study medication Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
Quality of life 18 Month after end of treatment of the last patient EORTC QUOL Questionnaire
Trial Locations
- Locations (133)
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Essen, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt, Germany
Specialist Practice for Oncology
🇩🇪Aschaffenburg, Germany
Internistische Praxis - Arnstadt
🇩🇪Arnstadt, Germany
Klinikum Erfurt
🇩🇪Erfurt, Germany
Onkologische Schwerpunktpraxis
🇩🇪Hildesheim, Germany
Onkolog - Haematolog Schwerpunktpraxis
🇩🇪Berlin, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Internistische Praxis - Bad Salzuflen
🇩🇪Bad Salzuflen, Germany
Onkologische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Praxis DR. J. Weniger
🇩🇪Erfurt, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Kreiskrankenhaus Aurich
🇩🇪Aurich, Germany
Internistische Praxis - Bayreuth
🇩🇪Bayreuth, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Kreiskrankenhaus
🇩🇪Bad Hersfeld, Germany
Krankenhaus Bietigheim
🇩🇪Bietigheim, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Internistische Gemeinschaftspraxis - Bergisch Gladbach
🇩🇪Bergisch Gladbach, Germany
St. Georg Klinikum Eisenach GmbH
🇩🇪Eisenach, Germany
Praxis fuer Haematologie/Onkologie - Erfurt
🇩🇪Erfurt, Germany
Internistische Praxisgemeinschaft
🇩🇪Germering, Germany
University of Muenster
🇩🇪Muenster, Germany
Staedtisches Klinikum Magdeburg - Altstadt
🇩🇪Magdeburg, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Sudharz-Krankenhaus Nordhausen gGmbH
🇩🇪Nordhausen, Germany
Internistische Gemeinschaftspraxis - Potsdam
🇩🇪Potsdam, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
🇩🇪Weilheim, Germany
Internistische Praxis - Zittau
🇩🇪Zittau, Germany
Caritas-Krankenhaus Bad Mergentheim
🇩🇪Bad Mergentheim, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
🇩🇪Berlin, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Internistische Praxis - Chemnitz
🇩🇪Chemnitz, Germany
Krankenhaus Benrath
🇩🇪Dusseldorf, Germany
Internistische Gemeinschaftspraxis - Forchheim
🇩🇪Forchheim, Germany
Onkologische Gemeinschaftspraxis - Hoevelhof
🇩🇪Hoevelhof, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Charite - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Internistische Praxis - Berlin
🇩🇪Berlin, Germany
Onkologische Gemeinschaftspraxis - Dresden
🇩🇪Dresden, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Internistische/Onkologische Praxis - Erfurt
🇩🇪Erfurt, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Onkologische Praxis - Essen
🇩🇪Essen, Germany
Gemeinschaftspraxis - Freiburg
🇩🇪Freiburg, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
🇩🇪Giessen, Germany
Klinik fuer Radioonkologie und Strahlentherapie
🇩🇪Goeppingen, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
🇩🇪Gustrow, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Internistische Praxis - Halle
🇩🇪Halle, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
🇩🇪Hannover, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
🇩🇪Herrsching, Germany
Universitaets-Kinderklinik Heidelberg
🇩🇪Heidelberg, Germany
Evang. Hospital
🇩🇪Holzminden, Germany
Internistische Gemeinschaftspraxis - Jena
🇩🇪Jena, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Koeln, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Onkologische Gemeinschaftspraxis - Kaiserslautern
🇩🇪Kaiserslautern, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
St. Vincentius-Kliniken
🇩🇪Karlsruhe, Germany
Internistische Praxis - Wendlingen
🇩🇪Wendlingen, Germany
Klinikum Kempten Oberallgaeu
🇩🇪Kempten, Germany
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Internistische Praxis - Landshut
🇩🇪Landshut, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Internistische Praxis - Ludwigsburg
🇩🇪Ludwigsburg, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munich, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Haematologische Praxis - Moenchengladbach
🇩🇪Moenchengladbach, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
🇩🇪Muenchen, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Internistische Praxis - Muhr am See
🇩🇪Muhr am See, Germany
Internistische Gemeinschaftspraxis - Offenbach
🇩🇪Offenbach, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
🇩🇪Munich, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Staedtische Klinikum-Kinderklinik
🇩🇪Rosenheim, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Paracelsus Karankenhaus Ruit
🇩🇪Ostfildern, Germany
Asklepios Klinik Pasewalk
🇩🇪Pasewalk, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Ernst Von Bergmann
🇩🇪Postdam, Germany
Vogtland - Klinikum Plauen GMBH
🇩🇪Plauen, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
🇩🇪Saarbruecke, Germany
Haematologische/Onkologische Schwerpunktpraxis - Rostock
🇩🇪Rostock, Germany
Klinikum Schwerin
🇩🇪Schwerin, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Haematologische Praxis
🇩🇪Stuttgart, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Internistische Gemeinschaftspraxis - Stuttgart
🇩🇪Stuttgart, Germany
Marienhospital Stuttgart
🇩🇪Stuttgart, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
🇩🇪Tuebingen, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Onkologische Gemeinschaftspraxis - Trier
🇩🇪Trier, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Gemeinschaftspraxis
🇩🇪Worms, Germany
Kliniken St. Antonius
🇩🇪Wuppertal 2, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Praxis fuer Haematologie und Internistische Onkologie - Greifswald
🇩🇪Greifswald, Germany
Klinikum Garmisch - Partenkirchen GmbH
🇩🇪Garmisch-Partenkirchen, Germany
Evang. Waldkrankenhaus Spandau
🇩🇪Berlin, Germany
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
🇩🇪Heilbronn, Germany
Internistische Praxis - Gerlingen
🇩🇪Gerlingen, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Internistische Praxis - Ingolstadt
🇩🇪Ingolstadt, Germany