Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
NCT ID: NCT00281918
Last Updated: 2013-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
817 participants
INTERVENTIONAL
2003-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fludarabine+Cyclophosphamide+Rituximab (FCR)
Rituximab
Intravenous repeating dose
Cyclophosphamide
Intravenous repeating dose
Fludarabine Phosphate
Intravenous repeating dose
Fludarabine+Cyclophosphamide (FC)
Cyclophosphamide
Intravenous repeating dose
Fludarabine Phosphate
Intravenous repeating dose
Interventions
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Rituximab
Intravenous repeating dose
Cyclophosphamide
Intravenous repeating dose
Fludarabine Phosphate
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
* Meets 1 of the following criteria:
* Binet stage C disease
* Binet stage B disease AND ≥ 1 of the following signs or symptoms\*:
* B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
* Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \> 50 G/I)
* Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
* Massive, progressive or painful splenomegaly or hypersplenism
* Massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
* Occurrence of symptomatic hyperviscosity problems at leukocyte counts \> 200 G/I (symptomatic leukostasis) NOTE: \* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
* No Binet stage A disease
* No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Cumulative Illness Rating Scale (CIRS) score \> 6
* Life expectancy \> 6 months
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase and transaminases ≤ 2 times ULN
* Creatinine clearance ≥ 70 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study treatment
* No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
* No cerebral dysfunction that precludes chemotherapy
* No active bacterial, viral, or fungal infection
* No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
* No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
* No medical or psychological condition that would preclude study therapy
* No concurrent disease that requires prolonged (\> 1 month) therapy involving glucocorticoids
PRIOR CONCURRENT THERAPY:
* No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy
18 Years
ALL
No
Sponsors
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German CLL Study Group
OTHER
Hoffmann-La Roche
INDUSTRY
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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Gosford Hospital
Gosford, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
Westmead - Wentworthville, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, , Austria
Hanuschkrankenhaus
Vienna, , Austria
Rudolfinerhaus
Vienna, , Austria
AZ Sint-Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , Belgium
Masaryk University Hospital
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
University Hospital - Olomouc
Olomouc, , Czechia
University Hospital in Pilsen - Lochotin
Pilsen-Lochotin, , Czechia
First Medical Clinic of Charles University Hospital
Prague, , Czechia
Copenhagen County Herlev University Hospital
Copenhagen, , Denmark
Vejle Sygehus
Vejle, , Denmark
Hopital Louis Pasteur
Colmar, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, , France
Praxis Fur Hamatologie und Onkologie Ahaus
Ahaus, , Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, , Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, , Germany
Klinikum Augsburg
Augsburg, , Germany
Humaine - Clinic
Bad Saarow, , Germany
Internistische Praxis - Bayreuth
Bayreuth, , Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, , Germany
Krankenhaus Bietigheim
Bietigheim, , Germany
Augusta-Kranken-Anstalt gGmbH
Bochum, , Germany
Marienhospital Bottrop gGmbH
Bottrop, , Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, , Germany
Krankenhaus Burglengenfeld
Burglengenfeld, , Germany
Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
Coesfeld, , 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
Internistische Praxis - Dusseldorf
Düsseldorf, , Germany
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
Düsseldorf, , Germany
Krankenhaus Benrath
Düsseldorf, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
St. Georg Klinikum Eisenach GmbH
Eisenach, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Internistiche Praxis
Erfurt, , Germany
Onkologische Schwerpunkt Praxis
Erlangen, , Germany
St. Antonius Hospital
Eschweiler, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Evangelisches Krankenhaus Essen Werden
Essen, , Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, , Germany
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, , Germany
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, , Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), , Germany
Gemeinschaftspraxis - Freiburg
Freiburg im Breisgau, , Germany
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, , Germany
Internistische Praxis - Gerlingen
Gerlingen, , Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, , Germany
Internistische Praxis - Halle
Halle, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, , Germany
Evangelische Krankenhaus Hamm
Hamm, , Germany
Krankenhaus Siloah - Medizinische Klinik II
Hanover, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Marienhospital at Ruhr University Bochum
Herne, , Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching am Ammersee, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, , Germany
Gemeinschaftspraxis Innere Medizin
Jena, , Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
St. Vincentius-Kliniken
Karlsruhe, , Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, , Germany
Klinikum Kempten Oberallgaeu
Kempten, , Germany
Internistische Praxis - Kiel
Kiel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Praxis fuer Haematologie und Onkologie
Koblenz, , Germany
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
Koblez, , Germany
Internistische Onkologische Praxis - Kronach
Kronach, , Germany
Klinikum Landshut
Landshut, , Germany
Onkologische Schwerpunktpraxis - Leer
Leer, , Germany
Klinikum "St. Georg" Leipzig
Leipzig, , Germany
Klinikum Lippe - Lemgo
Lemgo, , Germany
Internistische Praxis - Loerrach
Loerrach, , Germany
Gemeinschaftspraxis - Ludwigshafen
Ludwigshafen, , Germany
Sana Kliniken Luebeck
Lübeck, , Germany
Internistische Gemeinschaftspraxis - Magdeburg
Magdeburg, , Germany
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Universitatsklinik Mainz
Mainz, , Germany
III Medizinische Klinik Mannheim
Mannheim, , Germany
Krankenhaus Maria Hilf GmbH
Mönchengladbach, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Haematologische Schwerpunktpraxis
Munich, , Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
München, , Germany
University of Muenster
Münster, , Germany
Haematologisch - Onkologische Gemeinschaftspraxis
Münster, , Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, , Germany
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Gemeinschaftspraxis - Oberhausen
Oberhausen, , Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, , Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Asklepios Klinik Pasewalk
Pasewalk, , Germany
Municipal Hospital Complex
Pforzheim, , Germany
Klinikum Ernst Von Bergmann
Potsdam, , Germany
Elisabeth Krankenhaus
Recklinghausen, , Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, , Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, , Germany
Caritasklinik St. Theresia
Saarbrücken, , Germany
Nordwestkrankenhaus Sanderbusch
Sanderbusch, , Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, , Germany
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, , Germany
Haematologische Praxis
Stuttgart, , Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, , Germany
Diakonie Klinikum Stuttgart
Stuttgart, , Germany
Marienhospital Stuttgart
Stuttgart, , Germany
KKH Torgau
Torgau, , Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Praxis Fuer Internistische Haematologie / Onkologie
Troisdorf, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
Municipal Hospital Complex
Villingen-Schwenningen, , Germany
Praxis fur Innere Medizin - Wanzleben
Wanzleben, , Germany
Haematologische Praxis
Weiden, , Germany
Schwerpunktpraxis Hamatologie/Onkologie - Wesel
Wesel, , Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , Germany
Kliniken St. Antonius
Wuppertal, , Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, , Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Soroka University Medical Center
Beersheba, , Israel
BNAI Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Riverview Cancer Care Medical Associates, PC
Kfar Saba, , Israel
Kaplan Hospital
Rehovot, , Israel
Ospedale Oncologico A. Businco
Cagliari, , Italy
Fondazione Centro San Raffaele Del Monte Tabor
Milan, , Italy
Perugia Regional Cancer Center
Perugia, , Italy
Ospedale Sant' Eugenio
Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , Italy
Auckland City Hospital
Auckland, , New Zealand
Canterbury Health Laboratories
Christchurch, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Virgen Del La Salud
Toledo, , Spain
Countries
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References
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Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.
Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Dohner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561.
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Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.
Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.
Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Bottcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Dohner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.
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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.
Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.
Other Identifiers
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GCLLSG-CLL-8
Identifier Type: -
Identifier Source: secondary_id
EU-20560
Identifier Type: -
Identifier Source: secondary_id
ML17102
Identifier Type: -
Identifier Source: secondary_id
CDR0000454560
Identifier Type: -
Identifier Source: org_study_id