Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

NCT00281918 | Completed Phase 3 Results

• 4 other identifiers: CDR0000454560GCLLSG-CLL-8EU-20560ML17102
• Study Type: interventional
• Target: 817
• Locations: 10 countries
• Sites: 159

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.

Conditions

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

  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.

  Median observation time at time of analysis was approximately 21 months

• Final Analysis: Time to Progression-free Survival Event

  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.

  Median observation time was approximately 66.4 months

Secondary Outcomes (9)

• Event-free Survival (EFS)

  Median observation time at time of analysis was approximately 21 months

• Overall Survival (OS)

  Median observation time at time of analysis was approximately 21 months

• Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).

  Median observation time at time of analysis was approximately 21 months

• Final Analysis: Time to Overall Survival Event

  Median observation time was approximately 66.4 months

• Final Analysis: Time to Event-free Survival Event

  Median observation time was approximately 66.4 months

Study Arms (2)

Fludarabine+Cyclophosphamide+Rituximab (FCR)

EXPERIMENTAL

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine Phosphate

Fludarabine+Cyclophosphamide (FC)

ACTIVE COMPARATOR

Drug: Cyclophosphamide; Drug: Fludarabine Phosphate

Interventions

Rituximab DRUG

Intravenous repeating dose

Fludarabine+Cyclophosphamide+Rituximab (FCR)

Cyclophosphamide DRUG

Intravenous repeating dose

Fludarabine+Cyclophosphamide (FC); Fludarabine+Cyclophosphamide+Rituximab (FCR)

Fludarabine Phosphate DRUG

Intravenous repeating dose

Fludarabine+Cyclophosphamide (FC); Fludarabine+Cyclophosphamide+Rituximab (FCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• German CLL Study Group: collaborator

Study Sites (162)

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead - Wentworthville, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

Vienna, 1090, Austria

Location

Hanuschkrankenhaus

Vienna, A-1140, Austria

Location

Rudolfinerhaus

Vienna, A-1190, Austria

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

Masaryk University Hospital

Brno, 62500, Czechia

Location

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital in Pilsen - Lochotin

Pilsen-Lochotin, 30460, Czechia

Location

First Medical Clinic of Charles University Hospital

Prague, 128 08, Czechia

Location

Copenhagen County Herlev University Hospital

Copenhagen, DK-2730, Denmark

Location

Vejle Sygehus

Vejle, DK-7100, Denmark

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Praxis Fur Hamatologie und Onkologie Ahaus

Ahaus, 48683, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

Ansbach, 91522, Germany

Location

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

Augsburg, 86150, Germany

Location

Klinikum Augsburg

Augsburg, DOH-86156, Germany

Location

Humaine - Clinic

Bad Saarow, 15526, Germany

Location

Internistische Praxis - Bayreuth

Bayreuth, 95448, Germany

Location

Internistische Gemeinschaftspraxis - Berlin

Berlin, 13347, Germany

Location

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, D-33602, Germany

Location

Krankenhaus Bietigheim

Bietigheim, D-74321, Germany

Location

Augusta-Kranken-Anstalt gGmbH

Bochum, D-44791, Germany

Location

Marienhospital Bottrop gGmbH

Bottrop, D-46236, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, D-28239, Germany

Location

Krankenhaus Burglengenfeld

Burglengenfeld, D-93133, Germany

Location

Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

Coesfeld, 48653, Germany

Location

Praxis Fuer Haematologie Internistische Onkologie

Cologne, D-50677, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Onkologische Schwerpunktpraxis

Cottbus, D-03046, Germany

Location

Onkologische Gemeinschaftspraxis - Dresden

Dresden, 01127, Germany

Location

Internistische Praxis - Dusseldorf

Düsseldorf, 40211, Germany

Location

Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

Düsseldorf, 40489, Germany

Location

Krankenhaus Benrath

Düsseldorf, 40593, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

Location

St. Georg Klinikum Eisenach GmbH

Eisenach, 99817, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99012, Germany

Location

Internistiche Praxis

Erfurt, 99084, Germany

Location

Onkologische Schwerpunkt Praxis

Erlangen, D-91052, Germany

Location

St. Antonius Hospital

Eschweiler, DOH-52249, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Evangelisches Krankenhaus Essen Werden

Essen, D-45239, Germany

Location

Staedtische Kliniken Esslingen

Esslingen am Neckar, D-73730, Germany

Location

Internistische Gemeinschaftspraxis - Forchheim

Forchheim, 91301, Germany

Location

Staedtische Kliniken Frankfurt am Main - Hoechst

Frankfurt, D-65929, Germany

Location

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), D-15236, Germany

Location

Gemeinschaftspraxis - Freiburg

Freiburg im Breisgau, 79098, Germany

Location

Klinikum Garmisch - Partenkirchen GmbH

Garmisch-Partenkirchen, D-82467, Germany

Location

Internistische Praxis - Gerlingen

Gerlingen, 70839, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

Giessen, 35392, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17475, Germany

Location

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, D-58095, Germany

Location

Internistische Praxis - Halle

Halle, 06108, Germany

Location

Universitaetsklinikum Halle

Halle, D-06120, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

St. Marien-Hospital Hamm - Klinik Knappenstrasse

Hamm, D-59071, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, DOH-59063, Germany

Location

Krankenhaus Siloah - Medizinische Klinik II

Hanover, D-30449, Germany

Location

Universitatsklinikum Heidelberg

Heidelberg, D-69115, Germany

Location

Marienhospital at Ruhr University Bochum

Herne, D-44625, Germany

Location

Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

Herrsching am Ammersee, D-82211, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66424, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Gemeinschaftspraxis Innere Medizin

Jena, D-07743, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

St. Vincentius-Kliniken

Karlsruhe, D-76137, Germany

Location

Internistische Gemeinschaftspraxis - Kassel

Kassel, D-34117, Germany

Location

Klinikum Kempten Oberallgaeu

Kempten, D-87439, Germany

Location

Internistische Praxis - Kiel

Kiel, 24105, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24116, Germany

Location

Praxis fuer Haematologie und Onkologie

Koblenz, D-56068, Germany

Location

Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

Koblez, D-56068, Germany

Location

Internistische Onkologische Praxis - Kronach

Kronach, 96317, Germany

Location

Klinikum Landshut

Landshut, 84034, Germany

Location

Onkologische Schwerpunktpraxis - Leer

Leer, D-26789, Germany

Location

Klinikum "St. Georg" Leipzig

Leipzig, D-04126, Germany

Location

Klinikum Lippe - Lemgo

Lemgo, D-32657, Germany

Location

Internistische Praxis - Loerrach

Loerrach, D-79539, Germany

Location

Gemeinschaftspraxis - Ludwigshafen

Ludwigshafen, 67061, Germany

Location

Sana Kliniken Luebeck

Lübeck, 23560, Germany

Location

Internistische Gemeinschaftspraxis - Magdeburg

Magdeburg, D-39104, Germany

Location

Staedtisches Klinikum Magdeburg - Altstadt

Magdeburg, D-39104, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Universitatsklinik Mainz

Mainz, D-55101, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68305, Germany

Location

Krankenhaus Maria Hilf GmbH

Mönchengladbach, D-41063, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Haematologische Schwerpunktpraxis

Munich, D-81679, Germany

Location

Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

München, D-81241, Germany

Location

University of Muenster

Münster, D-48129, Germany

Location

Haematologisch - Onkologische Gemeinschaftspraxis

Münster, D-48149, Germany

Location

Onkologische Schwerpunktpraxis Dr. Schmidt

Neunkirchen, D-66538, Germany

Location

Praxis fuer Haematologie und Interne Onkologie

Norderstedt, 22844, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Gemeinschaftspraxis - Oberhausen

Oberhausen, D-46045, Germany

Location

Internistische Gemeinschaftspraxis - Offenbach

Offenbach, D-63065, Germany

Location

Internistische Gemeinschaftspraxis - Oldenburg

Oldenburg, D-26121, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

Asklepios Klinik Pasewalk

Pasewalk, 17309, Germany

Location

Municipal Hospital Complex

Pforzheim, D-75178, Germany

Location

Klinikum Ernst Von Bergmann

Potsdam, D-14467, Germany

Location

Elisabeth Krankenhaus

Recklinghausen, 45661, Germany

Location

Krankenhaus Barmherzige Brueder Regensburg

Regensburg, D-93049, Germany

Location

Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

Rostock, D-18055, Germany

Location

Caritasklinik St. Theresia

Saarbrücken, D-66113, Germany

Location

Nordwestkrankenhaus Sanderbusch

Sanderbusch, 26452, Germany

Location

St. Marien - Krankenhaus Siegen GMBH

Siegen, D-57072, Germany

Location

Internistische Gemeinschaftspraxis - Stuttgart

Stuttgart, 70176, Germany

Location

Haematologische Praxis

Stuttgart, D-70173, Germany

Location

Klinik fuer Onkologie - Katharinenhospital Stuttgart

Stuttgart, D-70174, Germany

Location

Diakonie Klinikum Stuttgart

Stuttgart, D-70176, Germany

Location

Marienhospital Stuttgart

Stuttgart, D-70199, Germany

Location

KKH Torgau

Torgau, 04860, Germany

Location

Onkologische Gemeinschaftspraxis - Trier

Trier, 54290, Germany

Location

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54219, Germany

Location

Praxis Fuer Internistische Haematologie / Onkologie

Troisdorf, 53840, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

Municipal Hospital Complex

Villingen-Schwenningen, D-78045, Germany

Location

Praxis fur Innere Medizin - Wanzleben

Wanzleben, 39164, Germany

Location

Haematologische Praxis

Weiden, D-92637, Germany

Location

Schwerpunktpraxis Hamatologie/Onkologie - Wesel

Wesel, 46483, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Kliniken St. Antonius

Wuppertal, D-42283, Germany

Location

Hamatologisch - Onkologische Praxis Wurzburg

Würzburg, 97070, Germany

Location

Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

Würzburg, D-97080, Germany

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

BNAI Zion Medical Center

Haifa, 31048, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Riverview Cancer Care Medical Associates, PC

Kfar Saba, 44281, Israel

Location

Kaplan Hospital

Rehovot, 76100, Israel

Location

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

Location

Fondazione Centro San Raffaele Del Monte Tabor

Milan, 20132, Italy

Location

Perugia Regional Cancer Center

Perugia, 06122, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Canterbury Health Laboratories

Christchurch, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Virgen Del La Salud

Toledo, 45004, Spain

Location

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• 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.

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MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Cyclophosphamide; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

800-821-8590

Study Officials

• Michael Hallek, MD

  Medizinische Universitaetsklinik I at the University of Cologne

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: July 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: October 1, 2011
• Last Updated: September 19, 2013
• Results First Posted: March 29, 2011

Record last verified: 2013-09

Locations

IT (5); AU (6); IL (6); FR (6); NZ (3); ES (2); BE (6); DK (2); CZ (5); DE (118)