Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
NCT ID: NCT00276848
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
375 participants
INTERVENTIONAL
1999-07-31
2007-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fludarabine plus Cyclophosphamide
Fludarabine plus Cyclophosphamide
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
Fludarabine
Fludarabine
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
Interventions
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Fludarabine plus Cyclophosphamide
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
Fludarabine
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)
* Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms
* Binet stage A is acceptable, if there are B-symptoms
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 6 months
* No severe organ dysfunction
* No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia
PRIOR CONCURRENT THERAPY:
* No prior or concurrent chemotherapy
18 Years
65 Years
ALL
No
Sponsors
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German CLL Study Group
OTHER
Responsible Party
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Principal Investigators
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Michael Hallek, MD
Role: STUDY_CHAIR
Medizinische Universitaetsklinik I at the University of Cologne
Locations
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Allgemeines Krankenhaus - Universitatskliniken
Vienna, , Austria
Hanuschkrankenhaus
Vienna, , Austria
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, , Germany
Internistische Praxis - Arnstadt
Arnstadt, , Germany
Specialist Practice for Oncology
Aschaffenburg, , Germany
Klinikum Augsburg
Augsburg, , Germany
Kreiskrankenhaus Aurich
Aurich, , Germany
Kreiskrankenhaus
Bad Hersfeld, , Germany
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, , Germany
Humaine - Clinic
Bad Saarow, , Germany
Internistische Praxis - Bad Salzuflen
Bad Salzuflen, , Germany
Internistische Praxis - Bayreuth
Bayreuth, , Germany
Internistische Gemeinschaftspraxis - Bergisch Gladbach
Bergisch Gladbach, , Germany
Charite - Campus Charite Mitte
Berlin, , Germany
Onkolog - Haematolog Schwerpunktpraxis
Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Onkologische Gemeinschaftspraxis - Berlin
Berlin, , Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, , Germany
Charite - Campus Virchow Klinikum
Berlin, , Germany
Evang. Waldkrankenhaus Spandau
Berlin, , Germany
Internistische Praxis - Berlin
Berlin, , Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, , Germany
Krankenhaus Bietigheim
Bietigheim, , Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, , Germany
Internistische Praxis - Chemnitz
Chemnitz, , Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, , Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Onkologische Schwerpunktpraxis
Cottbus, , Germany
Onkologische Gemeinschaftspraxis - Dresden
Dresden, , Germany
Krankenhaus Benrath
Düsseldorf, , Germany
St. Georg Klinikum Eisenach GmbH
Eisenach, , Germany
Hans - Susemihl - Krankenhaus
Emden, , Germany
Internistische/Onkologische Praxis - Erfurt
Erfurt, , Germany
Praxis DR. J. Weniger
Erfurt, , Germany
Klinikum Erfurt
Erfurt, , Germany
Praxis fuer Haematologie/Onkologie - Erfurt
Erfurt, , Germany
Onkologische Schwerpunkt Praxis
Erlangen, , Germany
St. Antonius Hospital
Eschweiler, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Onkologische Praxis - Essen
Essen, , Germany
Evangelisches Krankenhaus Essen Werden
Essen, , Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, , Germany
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, , Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt, , Germany
Gemeinschaftspraxis - Freiburg
Freiburg im Breisgau, , Germany
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, , Germany
Internistische Praxis - Gerlingen
Gerlingen, , Germany
Internistische Praxisgemeinschaft
Germering, , Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, , Germany
Klinik fuer Radioonkologie und Strahlentherapie
Göppingen, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
Praxis fuer Haematologie und Internistische Onkologie - Greifswald
Greifswald, , Germany
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
Güstrow, , Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, , Germany
Internistische Praxis - Halle
Halle, , Germany
Internistische Gemeinschaftspraxis - Halle
Halle, , 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
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hanover, , Germany
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, , Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching am Ammersee, , Germany
Onkologische Schwerpunktpraxis
Hildesheim, , Germany
Evang. Hospital
Holzminden, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Onkologische Gemeinschaftspraxis - Hoevelhof
Hövelhof, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, , Germany
Internistische Praxis - Ingolstadt
Ingolstadt, , Germany
Internistische Gemeinschaftspraxis - Jena
Jena, , Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, , Germany
Onkologische Gemeinschaftspraxis - Kaiserslautern
Kaiserslautern, , Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
St. Vincentius-Kliniken
Karlsruhe, , Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, , Germany
Klinikum Kempten Oberallgaeu
Kempten, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Internistische Onkologische Praxis - Kronach
Kronach, , Germany
Internistische Praxis - Landshut
Landshut, , Germany
Onkologische Schwerpunktpraxis - Leer
Leer, , Germany
Klinikum Lippe - Lemgo
Lemgo, , Germany
Internistische Praxis - Ludwigsburg
Ludwigsburg, , Germany
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
III Medizinische Klinik Mannheim
Mannheim, , Germany
Haematologische Praxis - Moenchengladbach
Mönchengladbach, , Germany
Internistische Praxis - Muhr am See
Muhr am See, , Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
Munich, , Germany
Munich Oncologic Practice at Elisenhof
Munich, , Germany
Krankenhaus Muenchen Schwabing
Munich, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
München, , Germany
University of Muenster
Münster, , 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
Nuremberg, , Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, , Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, , Germany
Paracelsus Karankenhaus Ruit
Ostfildern, , Germany
Asklepios Klinik Pasewalk
Pasewalk, , Germany
Vogtland - Klinikum Plauen GMBH
Plauen, , Germany
Klinikum Ernst Von Bergmann
Postdam, , Germany
Internistische Gemeinschaftspraxis - Potsdam
Potsdam, , Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, , Germany
Staedtische Klinikum-Kinderklinik
Rosenheim, , Germany
Haematologische/Onkologische Schwerpunktpraxis - Rostock
Rostock, , Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, , Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbruecke, , Germany
Caritasklinik St. Theresia
Saarbrücken, , Germany
Klinikum Schwerin
Schwerin, , Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, , Germany
Haematologische Praxis
Stuttgart, , Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, , Germany
Diakonie Klinikum Stuttgart
Stuttgart, , Germany
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, , Germany
Marienhospital Stuttgart
Stuttgart, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, , Germany
Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
Tübingen, , Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
St. Marienhospital - Vechta
Vechta, , Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
Weilheim, , Germany
Internistische Praxis - Wendlingen
Wendlingen, , Germany
Gemeinschaftspraxis
Worms, , Germany
Kliniken St. Antonius
Wuppertal, , Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, , Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Internistische Praxis - Zittau
Zittau, , Germany
Countries
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References
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Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.
Cramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M. Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual. Leuk Res. 2014 Mar;38(3):284-5. doi: 10.1016/j.leukres.2013.11.015. Epub 2013 Dec 1. No abstract available.
Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Dohner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M; German CLL Study Group. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials. Haematologica. 2014 Jun;99(6):1095-100. doi: 10.3324/haematol.2013.096792. Epub 2014 Feb 28.
Jebaraj BMC, Tausch E, Landau DA, Bahlo J, Robrecht S, Taylor-Weiner AN, Bloehdorn J, Scheffold A, Mertens D, Bottcher S, Kneba M, Jager U, Zenz T, Wenger MK, Fingerle-Rowson G, Wendtner C, Fink AM, Wu CJ, Eichhorst B, Fischer K, Hallek M, Dohner H, Stilgenbauer S. Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia. Leukemia. 2019 Sep;33(9):2183-2194. doi: 10.1038/s41375-019-0446-4. Epub 2019 Mar 25.
Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.
Eichhorst BF, Busch R, Obwandner T, Kuhn-Hallek I, Herschbach P, Hallek M; German CLL Study Group. Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL Study Group. J Clin Oncol. 2007 May 1;25(13):1722-31. doi: 10.1200/JCO.2006.05.6929. Epub 2007 Mar 26.
Eichhorst BF, Busch R, Hopfinger G, Pasold R, Hensel M, Steinbrecher C, Siehl S, Jager U, Bergmann M, Stilgenbauer S, Schweighofer C, Wendtner CM, Dohner H, Brittinger G, Emmerich B, Hallek M; German CLL Study Group. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006 Feb 1;107(3):885-91. doi: 10.1182/blood-2005-06-2395. Epub 2005 Oct 11.
Other Identifiers
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EU-20538
Identifier Type: -
Identifier Source: secondary_id
GCLLSG-153
Identifier Type: -
Identifier Source: secondary_id
ISRCTN75653261
Identifier Type: -
Identifier Source: secondary_id
MEDAC-GCLLSG-CLL4
Identifier Type: -
Identifier Source: secondary_id
CDR0000455094
Identifier Type: OTHER
Identifier Source: secondary_id
CLL4
Identifier Type: -
Identifier Source: org_study_id
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