Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression
4 other identifiers
interventional
825
3 countries
91
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. 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. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
Longer than P75 for phase_3
91 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
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 23, 2019
May 1, 2019
1.7 years
January 10, 2006
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event-free survival
Development of a new prognostic staging system
Secondary Outcomes (10)
Progression free survival
Overall survival
Time to progression to Binet stages B and C
Time to treatment
Quality of life
- +5 more secondary outcomes
Study Arms (3)
Cohort I (FCR)
EXPERIMENTALPatients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.
Cohort II (W&W)
NO INTERVENTIONPatients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort II receive no treatment at all (watch \& wait).
Cohort III (W&W)
NO INTERVENTIONPatients with less than 2 risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) are assigned directly to cohort III and receive no treatment at all (watch \& wait).
Interventions
cycle1: 375 mg/m² i.v., d1, q28d cycles 2-6: 500 mg/m² i.v., d1, q28d
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 (91)
Universitaetsklinik fuer Innere Medizin I
Vienna, A-1090, Austria
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054, France
Centre Hospitalier Regional et Universitaire d'Angers
Angers, 49033, France
Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
Hopital Avicenne
Bobigny, 93009, France
CHU de Caen
Caen, 14033, France
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, 63058, France
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000, France
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043, France
Centre Jean Bernard
Le Mans, 72000, France
Centre Hospital Universitaire Hop Huriez
Lille, 59037, France
Hopital Edouard Herriot - Lyon
Lyon, 69437, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273, France
Centre Hospitalier de Meaux
Meaux, 77104, France
CHR Hotel Dieu
Nantes, 44093, France
Hopital Saint-Louis
Paris, 75475, France
CHU Pitie-Salpetriere
Paris, 75651, France
Hopital Necker
Paris, 75743, France
Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Poitiers
Poitiers, 86021, France
CHU - Robert Debre
Reims, 51092, France
Centre Henri Becquerel
Rouen, 76038, France
Hopital Universitaire Hautepierre
Strasbourg, 67098, France
CHU de Toulouse, Hotel Dieu
Toulouse, 31059, France
CHU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Praxis fuer Innere Medizin Haematologie und Internistische Onkologie
Alsfeld, 36304, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, 86150, Germany
Kreiskrankenhaus Aurich
Aurich, 26603, Germany
Klinikum am Bamberg
Bamberg, 96049, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 13347, Germany
St. Hedwig Krankenhaus
Berlin, D-10115, Germany
Internistische Gemeinschaftspraxis Betzdorf
Betzdorf, D-57518, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, D-28239, Germany
Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
Coesfeld, 48653, Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, D-40225, Germany
Helios Klinikum Erfurt
Erfurt, 99012, Germany
Onkologische Schwerpunkt Praxis
Erlangen, D-91052, Germany
St. Antonius Hospital
Eschweiler, DOH-52249, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, 91301, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), D-15236, Germany
Internistische Gemeinschaftspraxis - Friedberg
Friedberg, 86316, Germany
Unknown Facility
Fürstenzell, 94981, Germany
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, D-82467, Germany
Internistische Praxisgemeinschaft
Germering, 82110, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, 35392, Germany
Universitaetsklinikum Goettingen
Göttingen, D-37075, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17475, Germany
Maria-Josef-Hospital Greven GmbH
Greven, 48268, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, D-58095, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, 06110, Germany
Universitaetsklinikum Halle
Halle, D-06120, Germany
Krankenhaus Siloah - Medizinische Klinik II
Hanover, D-30449, Germany
Praxis Dr. med Freddy Henne
Hechingen, D-72379, Germany
Universitatsklinikum Heidelberg
Heidelberg, D-69120, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, D-34117, Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24116, Germany
Internistische Onkologische Praxis - Kronach
Kronach, 96317, Germany
Internistische Praxis - Landshut
Landshut, 84028, Germany
Caritas - Krakenhaus Lebach
Lebach, 66822, Germany
Onkologische Schwerpunktpraxis - Leer
Leer, D-26789, Germany
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, D-39104, Germany
Gemeinschaftspraxis
Mannheim, D-68161, Germany
Klinikum Minden
Minden, D-32423, Germany
Unknown Facility
Monchenglasbach/Rheydt, D-41239, Germany
Haematologische Praxis - Moenchengladbach
Mönchengladbach, D-41239, Germany
Munich Oncologic Practice at Elisenhof
Munich, D-80335, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81241, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
Munich, D-81245, Germany
Haematologische Schwerpunktpraxis
Munich, D-81679, Germany
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, D-73557, Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, D-63065, Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, D-26121, Germany
Unknown Facility
Pforzheim, 75179, Germany
Internistische Schwerpunktpraxis
Rüsselsheim am Main, 65428, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbrücken, 66113, Germany
Diakonie - Krankenhaus
Schwäbisch Hall, 74523, Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072, Germany
Unknown Facility
Singen, D-78224, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Diakonie Klinikum Stuttgart
Stuttgart, D-70176, Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, 54290, Germany
Universitaetsklinikum Tuebingen
Tübingen, D-72076, Germany
Praxis fuer Haematologie und Onkologie
Twistringen, D-27239, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081, Germany
St. Marienhospital - Vechta
Vechta, D-49377, Germany
Burkhard and Reimann Gemeinschaftspraxis
Worms, DOH-67547, Germany
Related Publications (2)
Sachanas 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: 31092457BACKGROUNDHerling CD, Cymbalista F, Gross-Ophoff-Muller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Lepretre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Dohner H, Leblond V, Kneba M, Letestu R, Bottcher S, Stilgenbauer S, Hallek M, Levy V. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020 Aug;34(8):2038-2050. doi: 10.1038/s41375-020-0747-7. Epub 2020 Feb 18.
PMID: 32071431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
October 1, 2005
Primary Completion
July 1, 2007
Study Completion
June 1, 2015
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share