⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

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.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Michael Hallek, MD

Affiliation: Medizinische Universitaetsklinik I at the University of Cologne

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: