The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Official Title: 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
Study ID: NCT00275054
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.
Detailed Description: OBJECTIVES: Primary * Compare the effect, in terms of event-free survival, of deferred versus immediate treatment with rituximab, fludarabine, and cyclophosphamide in patients with previously untreated Binet stage A chronic lymphocytic leukemia at high risk for disease progression. * Investigate and define a new prognostic staging system for patients with Binet stage A chronic lymphocytic leukemia. Secondary * Compare the time to progression to Binet stages B and C in patients treated with these regimens. * Compare the overall and progression-free survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the time to treatment in patients treated with these regimens. * Analyze the pharmacoeconomics of these regimens in these patients. * Determine the overall response rate (partial and complete) in patients included in the early treatment arm. * For patients included in the early treatment arm in complete remission, determine the percentage achieving complete molecular remission using the clone-specific CDR-III region as follow-up parameter. * Determine the duration of response in patients included in the early treatment arm. * Determine any adverse events related to treatment/safety of treatment. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk factor profile (\< 2 risk factors \[low risk\] vs ≥ 2 risk factors \[high risk\]). Low-risk patients are assigned to arm II. High-risk patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive rituximab IV on day 1, fludarabine IV on days 1-3, and cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for up to 6 courses. * Arm II: Patients undergo observation only until disease progression. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitaetsklinik fuer Innere Medizin I, Vienna, , Austria
Centre Hospitalier Universitaire d'Amiens, Amiens, , France
Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France
Centre Hospitalier Victor Dupouy, Argenteuil, , France
Hopital Avicenne, Bobigny, , France
CHU de Caen, Caen, , France
CHR Clermont Ferrand, Hotel Dieu, Clermont-Ferrand, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
CHU de Grenoble - Hopital de la Tronche, Grenoble, , France
Centre Jean Bernard, Le Mans, , France
Centre Hospital Universitaire Hop Huriez, Lille, , France
Hopital Edouard Herriot - Lyon, Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, , France
Centre Hospitalier de Meaux, Meaux, , France
CHR Hotel Dieu, Nantes, , France
Hopital Saint-Louis, Paris, , France
CHU Pitie-Salpetriere, Paris, , France
Hopital Necker, Paris, , France
Hopital Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU Poitiers, Poitiers, , France
CHU - Robert Debre, Reims, , France
Centre Henri Becquerel, Rouen, , France
Hopital Universitaire Hautepierre, Strasbourg, , France
CHU de Toulouse, Hotel Dieu, Toulouse, , France
CHU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France
Praxis fuer Innere Medizin Haematologie und Internistische Onkologie, Alsfeld, , Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg, Augsburg, , Germany
Kreiskrankenhaus Aurich, Aurich, , Germany
Klinikum am Bamberg, Bamberg, , Germany
Internistische Gemeinschaftspraxis - Berlin, Berlin, , Germany
St. Hedwig Krankenhaus, Berlin, , Germany
Internistische Gemeinschaftspraxis Betzdorf, Betzdorf, , Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH, Bremen, , 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
Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Onkologische Schwerpunkt Praxis, Erlangen, , Germany
St. Antonius Hospital, Eschweiler, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Internistische Gemeinschaftspraxis - Forchheim, Forchheim, , Germany
Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), , Germany
Internistische Gemeinschaftspraxis - Friedberg, Friedberg, , Germany
, Fürstenzell, , Germany
Klinikum Garmisch - Partenkirchen GmbH, Garmisch-Partenkirchen, , Germany
Internistische Praxisgemeinschaft, Germering, , Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie, Giessen, , Germany
Universitaetsklinikum Goettingen, Gottingen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Maria-Josef-Hospital Greven GmbH, Greven, , Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH, Hagen, , Germany
Internistische Gemeinschaftspraxis - Halle, Halle, , Germany
Universitaetsklinikum Halle, Halle, , Germany
Krankenhaus Siloah - Medizinische Klinik II, Hannover, , Germany
Praxis Dr. med Freddy Henne, Hechingen, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Internistische Gemeinschaftspraxis - Kassel, Kassel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus, Kiel, , Germany
Internistische Onkologische Praxis - Kronach, Kronach, , Germany
Internistische Praxis - Landshut, Landshut, , Germany
Caritas - Krakenhaus Lebach, Lebach, , Germany
Onkologische Schwerpunktpraxis - Leer, Leer, , Germany
Staedtisches Klinikum Magdeburg - Altstadt, Magdeburg, , Germany
Gemeinschaftspraxis, Mannheim, , Germany
Klinikum Minden, Minden, , Germany
Haematologische Praxis - Moenchengladbach, Moenchengladbach, , Germany
, Monchenglasbach/Rheydt, , Germany
Munich Oncologic Practice at Elisenhof, Munich, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, , Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen, Munich, , Germany
Haematologische Schwerpunktpraxis, Munich, , Germany
Klinikum Schwaebisch Gmuend Stauferklinik, Mutlangen, , Germany
Internistische Gemeinschaftspraxis - Offenbach, Offenbach, , Germany
Internistische Gemeinschaftspraxis - Oldenburg, Oldenburg, , Germany
, Pforzheim, , Germany
Internistische Schwerpunktpraxis, Russelsheim, , Germany
Schwerpunktpraxis fuer Haematologie und Onkologie, Saarbruecken, , Germany
Diakonie - Krankenhaus, Schwäbisch Hall, , Germany
St. Marien - Krankenhaus Siegen GMBH, Siegen, , Germany
, Singen, , Germany
Robert-Bosch-Krankenhaus, Stuttgart, , Germany
Diakonie Klinikum Stuttgart, Stuttgart, , Germany
Onkologische Gemeinschaftspraxis - Trier, Trier, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Praxis fuer Haematologie und Onkologie, Twistringen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm, , Germany
St. Marienhospital - Vechta, Vechta, , Germany
Burkhard and Reimann Gemeinschaftspraxis, Worms, , Germany
Name: Michael Hallek, MD
Affiliation: Medizinische Universitaetsklinik I at the University of Cologne
Role: PRINCIPAL_INVESTIGATOR