Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
6 other identifiers
interventional
375
2 countries
135
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 1999
Longer than P75 for phase_3
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 23, 2019
May 1, 2019
4 years
January 12, 2006
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Progression-free survival
date of randomization until progression of disease or death of any cause
18 Month after end of treatment of the last patient
Overall survival
Date of randomization until date of death
18 Month after end of treatment of the last patient
Duration of remission
Clinical response was defined according to the guidelines of the NCI-sponsored workshop
18 Month after end of treatment of the last patient
Secondary Outcomes (2)
Incidence of side effects
up to 28 days after the last dose of study medication
Quality of life
18 Month after end of treatment of the last patient
Study Arms (2)
Fludarabine plus Cyclophosphamide
ACTIVE COMPARATORFludarabine
ACTIVE COMPARATORInterventions
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 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
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (135)
Allgemeines Krankenhaus - Universitatskliniken
Vienna, A-1090, Austria
Hanuschkrankenhaus
Vienna, A-1140, Austria
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, D-91522, Germany
Internistische Praxis - Arnstadt
Arnstadt, D-99310, Germany
Specialist Practice for Oncology
Aschaffenburg, D-63739, Germany
Klinikum Augsburg
Augsburg, D-86156, Germany
Kreiskrankenhaus Aurich
Aurich, D-26603, Germany
Kreiskrankenhaus
Bad Hersfeld, D-36251, Germany
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, D-97980, Germany
Humaine - Clinic
Bad Saarow, D-15526, Germany
Internistische Praxis - Bad Salzuflen
Bad Salzuflen, D-32105, Germany
Internistische Praxis - Bayreuth
Bayreuth, D-95448, Germany
Internistische Gemeinschaftspraxis - Bergisch Gladbach
Bergisch Gladbach, D-51429, Germany
Charite - Campus Charite Mitte
Berlin, D-10117, Germany
Onkolog - Haematolog Schwerpunktpraxis
Berlin, D-10559, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Onkologische Gemeinschaftspraxis - Berlin
Berlin, D-13055, Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, D-13122, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, D-13347, Germany
Charite - Campus Virchow Klinikum
Berlin, D-13353, Germany
Evang. Waldkrankenhaus Spandau
Berlin, D-13589, Germany
Internistische Praxis - Berlin
Berlin, D-14052, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, D-14195, Germany
Krankenhaus Bietigheim
Bietigheim, D-74321, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, D-28239, Germany
Internistische Praxis - Chemnitz
Chemnitz, D-09119, Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Onkologische Schwerpunktpraxis
Cottbus, D-03046, Germany
Onkologische Gemeinschaftspraxis - Dresden
Dresden, D-01127, Germany
Krankenhaus Benrath
Düsseldorf, D-40593, Germany
St. Georg Klinikum Eisenach GmbH
Eisenach, D-99817, Germany
Hans - Susemihl - Krankenhaus
Emden, D-26721, Germany
Internistische/Onkologische Praxis - Erfurt
Erfurt, D-99084, Germany
Praxis DR. J. Weniger
Erfurt, D-99085, Germany
Klinikum Erfurt
Erfurt, D-99089, Germany
Praxis fuer Haematologie/Onkologie - Erfurt
Erfurt, D-99094, Germany
Onkologische Schwerpunkt Praxis
Erlangen, D-91052, Germany
St. Antonius Hospital
Eschweiler, D-52249, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Onkologische Praxis - Essen
Essen, D-45136, Germany
Evangelisches Krankenhaus Essen Werden
Essen, D-45239, Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, D-73730, Germany
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, D-91301, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt, D-15236, Germany
Gemeinschaftspraxis - Freiburg
Freiburg im Breisgau, D-79098, Germany
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, D-82467, Germany
Internistische Praxis - Gerlingen
Gerlingen, D-70839, Germany
Internistische Praxisgemeinschaft
Germering, D-82110, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, D-35392, Germany
Klinik fuer Radioonkologie und Strahlentherapie
Göppingen, D-73035, Germany
Universitaetsklinikum Goettingen
Göttingen, D-37075, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17487, Germany
Praxis fuer Haematologie und Internistische Onkologie - Greifswald
Greifswald, D-17489, Germany
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
Güstrow, D-18273, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, D-58095, Germany
Internistische Praxis - Halle
Halle, D-06108, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, D-06110, Germany
Asklepios Klinik St. Georg
Hamburg, D-20099, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, D-20246, Germany
Evangelische Krankenhaus Hamm
Hamm, D-59063, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, D-59071, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hanover, D-30169, Germany
Universitaets-Kinderklinik Heidelberg
Heidelberg, D-69120, Germany
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, D-74064, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching am Ammersee, D-82211, Germany
Onkologische Schwerpunktpraxis
Hildesheim, D-31134, Germany
Evang. Hospital
Holzminden, D-37603, Germany
Universitaetsklinikum des Saarlandes
Homburg, D-66421, Germany
Onkologische Gemeinschaftspraxis - Hoevelhof
Hövelhof, D-33161, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, D-55743, Germany
Internistische Praxis - Ingolstadt
Ingolstadt, D-85049, Germany
Internistische Gemeinschaftspraxis - Jena
Jena, D-07743, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Onkologische Gemeinschaftspraxis - Kaiserslautern
Kaiserslautern, D-67655, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, D-76133, Germany
St. Vincentius-Kliniken
Karlsruhe, D-76137, Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, D-34117, Germany
Klinikum Kempten Oberallgaeu
Kempten, D-87439, Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24105, Germany
Internistische Onkologische Praxis - Kronach
Kronach, D-96317, Germany
Internistische Praxis - Landshut
Landshut, D-84028, Germany
Onkologische Schwerpunktpraxis - Leer
Leer, D-26789, Germany
Klinikum Lippe - Lemgo
Lemgo, D-32657, Germany
Internistische Praxis - Ludwigsburg
Ludwigsburg, D-71638, Germany
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, D-39104, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, D-39120, Germany
III Medizinische Klinik Mannheim
Mannheim, D-68305, Germany
Haematologische Praxis - Moenchengladbach
Mönchengladbach, D-41239, Germany
Internistische Praxis - Muhr am See
Muhr am See, D-91735, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
Munich, D-80331, Germany
Munich Oncologic Practice at Elisenhof
Munich, D-80335, Germany
Krankenhaus Muenchen Schwabing
Munich, D-80804, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
München, D-81245, Germany
University of Muenster
Münster, D-48129, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, D-66538, Germany
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, D-22844, Germany
Sudharz-Krankenhaus Nordhausen gGmbH
Nordhausen, D-99734, Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90419, Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, D-63065, Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, D-26121, Germany
Paracelsus Karankenhaus Ruit
Ostfildern, D-73760, Germany
Asklepios Klinik Pasewalk
Pasewalk, D-17309, Germany
Vogtland - Klinikum Plauen GMBH
Plauen, D-08529, Germany
Klinikum Ernst Von Bergmann
Postdam, D-14467, Germany
Internistische Gemeinschaftspraxis - Potsdam
Potsdam, D-14467, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, D-93049, Germany
Staedtische Klinikum-Kinderklinik
Rosenheim, D-83022, Germany
Haematologische/Onkologische Schwerpunktpraxis - Rostock
Rostock, D-18057, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, D-18057, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbruecke, D-66113, Germany
Caritasklinik St. Theresia
Saarbrücken, D-66113, Germany
Klinikum Schwerin
Schwerin, D-19049, Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072, Germany
Haematologische Praxis
Stuttgart, D-70173, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, D-70174, Germany
Diakonie Klinikum Stuttgart
Stuttgart, D-70176, Germany
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, D-70176, Germany
Marienhospital Stuttgart
Stuttgart, D-70199, Germany
Robert-Bosch-Krankenhaus
Stuttgart, D-70376, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, D-54290, Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, D-54290, Germany
Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
Tübingen, D-72070, Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081, Germany
St. Marienhospital - Vechta
Vechta, D-49377, Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
Weilheim, D-82362, Germany
Internistische Praxis - Wendlingen
Wendlingen, D-73240, Germany
Gemeinschaftspraxis
Worms, D-67547, Germany
Kliniken St. Antonius
Wuppertal, D-42283, Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, D-97070, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Würzburg, D-97070, Germany
Internistische Praxis - Zittau
Zittau, D-02763, Germany
Related Publications (7)
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.
PMID: 21139079BACKGROUNDCramer 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.
PMID: 24412156BACKGROUNDGoede 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.
PMID: 24584349BACKGROUNDJebaraj 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.
PMID: 30911113BACKGROUNDSachanas 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.
PMID: 31092457BACKGROUNDEichhorst 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.
PMID: 17389338RESULTEichhorst 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.
PMID: 16219797RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 13, 2006
Study Start
July 1, 1999
Primary Completion
July 1, 2003
Study Completion
July 1, 2007
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share