Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00281918
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 817
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab - Fludarabine+Cyclophosphamide+Rituximab (FCR) Cyclophosphamide - Fludarabine+Cyclophosphamide+Rituximab (FCR) Fludarabine Phosphate - Fludarabine+Cyclophosphamide (FC) Cyclophosphamide - Fludarabine+Cyclophosphamide (FC) Fludarabine Phosphate -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Median observation time at time of analysis was approximately 21 months Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
Final Analysis: Time to Progression-free Survival Event Median observation time was approximately 66.4 months Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
- Secondary Outcome Measures
Name Time Method Event-free Survival (EFS) Median observation time at time of analysis was approximately 21 months Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.
Overall Survival (OS) Median observation time at time of analysis was approximately 21 months Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). Median observation time at time of analysis was approximately 21 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
Final Analysis: Time to Overall Survival Event Median observation time was approximately 66.4 months Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
Final Analysis: Time to Event-free Survival Event Median observation time was approximately 66.4 months Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) Median observation time was approximately 66.4 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death
Final Analysis: Duration of Response Median observation time was approximately 66.4 months Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response Median observation time was approximately 66.4 months CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) Median observation time was approximately 66.4 months The time from randomization to the start of a new treatment.
Trial Locations
- Locations (160)
Praxis Fur Hamatologie und Onkologie Ahaus
🇩🇪Ahaus, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
🇩🇪Augsburg, Germany
Onkologische Schwerpunktpraxis Bielefeld
🇩🇪Bielefeld, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
🇩🇪Muenchen, Germany
University of Muenster
🇩🇪Muenster, Germany
Onkologische Gemeinschaftspraxis - Trier
🇩🇪Trier, Germany
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
🇩🇪Dusseldorf, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Germany
Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
🇩🇪Coesfeld, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
Krankenhaus Benrath
🇩🇪Dusseldorf, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Essen, Germany
St. Georg Klinikum Eisenach GmbH
🇩🇪Eisenach, Germany
Internistiche Praxis
🇩🇪Erfurt, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Gemeinschaftspraxis - Freiburg
🇩🇪Freiburg, Germany
Internistische Praxis - Gerlingen
🇩🇪Gerlingen, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Internistische Praxis - Halle
🇩🇪Halle, Germany
Marienhospital at Ruhr University Bochum
🇩🇪Herne, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
🇩🇪Herrsching, Germany
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Universitaetsklinikum Halle
🇩🇪Halle, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
🇩🇪Koblez, Germany
Internistische Gemeinschaftspraxis - Magdeburg
🇩🇪Magdeburg, Germany
Krankenhaus Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Universitatsklinik Mainz
🇩🇪Mainz, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Haematologisch - Onkologische Gemeinschaftspraxis
🇩🇪Muenster, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead - Wentworthville, New South Wales, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Rudolfinerhaus
🇦🇹Vienna, Austria
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
🇦🇹Wien, Austria
AZ Sint-Jan
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Masaryk University Hospital
🇨🇿Brno, Czech Republic
University Hospital - Olomouc
🇨🇿Olomouc, Czech Republic
Clinique Universitaire De Mont-Godinne
🇧🇪Mont-Godinne Yvoir, Belgium
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
University Hospital in Pilsen - Lochotin
🇨🇿Pilsen-Lochotin, Czech Republic
Vejle Sygehus
🇩🇰Vejle, Denmark
Copenhagen County Herlev University Hospital
🇩🇰Copenhagen, Denmark
Centre Leon Berard
🇫🇷Lyon, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Internistische Praxis - Dusseldorf
🇩🇪Dusseldorf, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt (Oder), Germany
Klinikum Garmisch - Partenkirchen GmbH
🇩🇪Garmisch-Partenkirchen, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Krankenhaus Siloah - Medizinische Klinik II
🇩🇪Hannover, Germany
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
St. Vincentius-Kliniken
🇩🇪Karlsruhe, Germany
Klinikum Kempten Oberallgaeu
🇩🇪Kempten, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Gemeinschaftspraxis Innere Medizin
🇩🇪Jena, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Internistische Praxis - Kiel
🇩🇪Kiel, Germany
Praxis fuer Haematologie und Onkologie
🇩🇪Koblenz, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Klinikum Landshut
🇩🇪Landshut, Germany
Gemeinschaftspraxis - Ludwigshafen
🇩🇪Ludwigshafen, Germany
Sana Kliniken Luebeck
🇩🇪Luebeck, Germany
Staedtisches Klinikum Magdeburg - Altstadt
🇩🇪Magdeburg, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Haematologische Schwerpunktpraxis
🇩🇪Munich, Germany
Gemeinschaftspraxis - Oberhausen
🇩🇪Oberhausen, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany
Internistische Gemeinschaftspraxis - Offenbach
🇩🇪Offenbach, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Marienhospital Stuttgart
🇩🇪Stuttgart, Germany
KKH Torgau
🇩🇪Torgau, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Praxis Fuer Internistische Haematologie / Onkologie
🇩🇪Troisdorf, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Praxis fur Innere Medizin - Wanzleben
🇩🇪Wanzleben, Germany
Schwerpunktpraxis Hamatologie/Onkologie - Wesel
🇩🇪Wesel, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Kliniken St. Antonius
🇩🇪Wuppertal 2, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
BNAI Zion Medical Center
🇮🇱Haifa, Israel
Kaplan Hospital
🇮🇱Rehovot, Israel
Perugia Regional Cancer Center
🇮🇹Perugia, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hospital Virgen Del La Salud
🇪🇸Toledo, Spain
Hopital Louis Pasteur
🇫🇷Colmar, France
Internistische Praxis - Bayreuth
🇩🇪Bayreuth, Germany
Krankenhaus Burglengenfeld
🇩🇪Burglengenfeld, Germany
Onkologische Schwerpunktpraxis
🇩🇪Cottbus, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Staedtische Kliniken Frankfurt am Main - Hoechst
🇩🇪Frankfurt, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Krankenhaus Bietigheim
🇩🇪Bietigheim, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Cologne, Germany
Onkologische Gemeinschaftspraxis - Dresden
🇩🇪Dresden, Germany
Internistische Gemeinschaftspraxis - Forchheim
🇩🇪Forchheim, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
🇩🇪Giessen, Germany
First Medical Clinic of Charles University Hospital
🇨🇿Prague, Czech Republic
Klinikum Augsburg
🇩🇪Augsburg, Germany
Augusta-Kranken-Anstalt gGmbH
🇩🇪Bochum, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany
Klinikum "St. Georg" Leipzig
🇩🇪Leipzig, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Nordwestkrankenhaus Sanderbusch
🇩🇪Sanderbusch, Germany
Riverview Cancer Care Medical Associates, PC
🇮🇱Kfar Saba, Israel
Fondazione Centro San Raffaele Del Monte Tabor
🇮🇹Milano, Italy
Ospedale Sant' Eugenio
🇮🇹Rome, Italy
Internistische Praxis - Loerrach
🇩🇪Loerrach, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
🇩🇪Munich, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Asklepios Klinik Pasewalk
🇩🇪Pasewalk, Germany
Municipal Hospital Complex
🇩🇪Villingen-Schwenningen, Germany
Internistische Gemeinschaftspraxis - Stuttgart
🇩🇪Stuttgart, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Ospedale Oncologico A. Businco
🇮🇹Cagliari, Italy
Elisabeth Krankenhaus
🇩🇪Recklinghausen, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Haematologische Praxis
🇩🇪Weiden, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Canterbury Health Laboratories
🇳🇿Christchurch, New Zealand