Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia (CLL-8)
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Gosford Hospital
- Westmead Institute for Cancer Research at Westmead Hospital
- Royal Brisbane and Women's Hospital
- Princess Alexandra Hospital
- Peter MacCallum Cancer Centre
- Frankston Hospital
- Hanuschkrankenhaus
- Rudolfinerhaus
- Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
- AZ Sint-Jan
- Institut Jules Bordet
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Clinique Universitaire De Mont-Godinne
- Masaryk University Hospital
- Fakultni Nemocnice Hradec Kralove
- University Hospital - Olomouc
- University Hospital in Pilsen - Lochotin
- First Medical Clinic of Charles University Hospital
- Copenhagen County Herlev University Hospital
- Vejle Sygehus
- Hopital Louis Pasteur
- Hopital Andre Mignot
- Centre Leon Berard
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- Centre Hospitalier Universitaire de Rennes
- Institut de Cancerologie de la Loire
- Praxis Fur Hamatologie und Onkologie Ahaus
- Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
- Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
- Klinikum Augsburg
- Humaine - Clinic
- Internistische Praxis - Bayreuth
- Internistische Gemeinschaftspraxis - Berlin
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Onkologische Schwerpunktpraxis Bielefeld
- Krankenhaus Bietigheim
- Augusta-Kranken-Anstalt gGmbH
- Marienhospital Bottrop gGmbH
- DIAKO Ev. Diakonie Krankenhaus gGmbH
- Krankenhaus Burglengenfeld
- Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
- Praxis Fuer Haematologie Internistische Onkologie
- Medizinische Universitaetsklinik I at the University of Cologne
- Onkologische Schwerpunktpraxis
- Onkologische Gemeinschaftspraxis - Dresden
- Universitaetsklinikum Duesseldorf
- Internistische Praxis - Dusseldorf
- Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
- Krankenhaus Benrath
- St. Georg Klinikum Eisenach GmbH
- Helios Klinikum Erfurt
- Internistiche Praxis
- Onkologische Schwerpunkt Praxis
- St. Antonius Hospital
- Universitaetsklinikum Essen
- Evangelisches Krankenhaus Essen Werden
- Staedtische Kliniken Esslingen
- Internistische Gemeinschaftspraxis - Forchheim
- Klinikum Frankfurt (Oder) GmbH
- Staedtische Kliniken Frankfurt am Main - Hoechst
- Gemeinschaftspraxis - Freiburg
- Klinikum Garmisch - Partenkirchen GmbH
- Internistische Praxis - Gerlingen
- Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
- Universitaetsklinikum Goettingen
- Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
- St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
- Internistische Praxis - Halle
- Universitaetsklinikum Halle
- Asklepios Klinik St. Georg
- University Medical Center Hamburg - Eppendorf
- St. Marien-Hospital Hamm - Klinik Knappenstrasse
- Evangelische Krankenhaus Hamm
- Krankenhaus Siloah - Medizinische Klinik II
- Universitatsklinikum Heidelberg
- Marienhospital at Ruhr University Bochum
- Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
- Universitaetsklinikum des Saarlandes
- Clinic for Bone Marrow Transplantation and Hematology and Oncology
- Gemeinschaftspraxis Innere Medizin
- Staedtisches Klinikum Karlsruhe gGmbH
- St. Vincentius-Kliniken
- Internistische Gemeinschaftspraxis - Kassel
- Klinikum Kempten Oberallgaeu
- Internistische Praxis - Kiel
- University Hospital Schleswig-Holstein - Kiel Campus
- Praxis fuer Haematologie und Onkologie
- Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
- Internistische Onkologische Praxis - Kronach
- Klinikum Landshut
- Onkologische Schwerpunktpraxis - Leer
- Klinikum "St. Georg" Leipzig
- Klinikum Lippe - Lemgo
- Internistische Praxis - Loerrach
- Gemeinschaftspraxis - Ludwigshafen
- Sana Kliniken Luebeck
- Internistische Gemeinschaftspraxis - Magdeburg
- Staedtisches Klinikum Magdeburg - Altstadt
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Universitatsklinik Mainz
- III Medizinische Klinik Mannheim
- Krankenhaus Maria Hilf GmbH
- Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
- University of Muenster
- Haematologisch - Onkologische Gemeinschaftspraxis
- Klinikum der Universitaet Muenchen - Grosshadern Campus
- Staedtisches Krankenhaus Muenchen - Harlaching
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Haematologische Schwerpunktpraxis
- Onkologische Schwerpunktpraxis Dr. Schmidt
- Praxis fuer Haematologie und Interne Onkologie
- Klinikum Nuernberg - Klinikum Nord
- Gemeinschaftspraxis - Oberhausen
- Internistische Gemeinschaftspraxis - Offenbach
- Internistische Gemeinschaftspraxis - Oldenburg
- Klinikum Oldenburg
- Asklepios Klinik Pasewalk
- Municipal Hospital Complex
- Klinikum Ernst Von Bergmann
- Elisabeth Krankenhaus
- Krankenhaus Barmherzige Brueder Regensburg
- Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
- Caritasklinik St. Theresia
- Nordwestkrankenhaus Sanderbusch
- St. Marien - Krankenhaus Siegen GMBH
- Internistische Gemeinschaftspraxis - Stuttgart
- Haematologische Praxis
- Klinik fuer Onkologie - Katharinenhospital Stuttgart
- Diakonie Klinikum Stuttgart
- Marienhospital Stuttgart
- KKH Torgau
- Onkologische Gemeinschaftspraxis - Trier
- Krankenanstalt Mutterhaus der Borromaerinnen
- Praxis Fuer Internistische Haematologie / Onkologie
- Universitaetsklinikum Tuebingen
- Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
- Municipal Hospital Complex
- Praxis fur Innere Medizin - Wanzleben
- Haematologische Praxis
- Schwerpunktpraxis Hamatologie/Onkologie - Wesel
- Dr. Horst-Schmidt-Kliniken
- Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
- Kliniken St. Antonius
- Hamatologisch - Onkologische Praxis Wurzburg
- Soroka University Medical Center
- BNAI Zion Medical Center
- Rambam Medical Center
- Hadassah University Hospital
- Riverview Cancer Care Medical Associates, PC
- Kaplan Hospital
- Ospedale Oncologico A. Businco
- Fondazione Centro San Raffaele Del Monte Tabor
- Perugia Regional Cancer Center
- Ospedale Sant' Eugenio
- Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
- Auckland City Hospital
- Canterbury Health Laboratories
- Palmerston North Hospital
- Hospital General Universitario Morales Meseguer
- Hospital Virgen Del La Salud
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Fludarabine+Cyclophosphamide (FC)