Spots Global Cancer Trial Database for Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
Official Title: Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
Study ID: NCT00281892
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia. PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.
Detailed Description: OBJECTIVES: * Compare the efficacy of fludarabine with or without darbepoetin alfa in geriatric patients with chronic lymphocytic leukemia and relevant comorbidities. * Determine the effect of these regimens in reducing anemia, lowering the requirements of transfusion, and reducing the duration and frequency of hospitalization in these patients. * Determine the quality of life of patients treated with these regimens. * Determine event-free, progression-free, and overall survival of patients treated with these regimens. * Evaluate the medical-economical aspects of these regimens in these patients OUTLINE: This is a multicenter study. Patients are stratified according to hemoglobin value (\< 12 g/dL \[stratum 1\] vs \> 12 g/dL \[stratum 2\]). Patients are assigned to 1 of 2 treatment strata. * Stratum 1: Patients receive fludarabine IV on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses. Patients also receive darbepoetin alfa subcutaneously once weekly for up to 6 weeks. * Stratum 2: Patients receive fludarabine as in stratum 1. Quality of life is evaluated periodically. PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg, Augsburg, , Germany
Onkologische Schwerpunktpraxis und Tagesklinik Dres, Bad Soden, , Germany
Internistische Gemeinschaftspraxis - Berlin, Berlin, , Germany
Charite - Campus Charite Mitte, Berlin, , Germany
Augusta-Kranken-Anstalt gGmbH, Bochum, , Germany
Medizinische Universitaetsklinik I at the University of Cologne, Cologne, , Germany
Internistische Praxis - Dusseldorf, Dusseldorf, , Germany
Hans - Susemihl - Krankenhaus, Emden, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), , Germany
Internistische Praxis - Gerlingen, Gerlingen, , Germany
Internistische Praxisgemeinschaft, Germering, , Germany
Universitaetsklinikum Göttingen, Göttingen, , Germany
Internistische Gemeinschaftspraxis - Halle, Halle, , Germany
University Medical Center Hamburg - Eppendorf, Hamburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
Klinikum Kempten Oberallgaeu, Kempten, , 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, Magdeburg, , Germany
Hospital Maria-Hilf II, Monchengladbach, , Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen, Munchen, , Germany
Munich Oncologic Practice at Elisenhof, Munich, , Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen, Munich, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany
Haematologische Schwerpunktpraxis, Munich, , Germany
Klinikum Schwaebisch Gmuend Stauferklinik, Mutlangen, , Germany
Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier, München, , Germany
Onkologische Schwerpunktpraxis Dr. Schmidt, Neunkirchen, , Germany
Praxis fuer Haematologie und Interne Onkologie, Norderstedt, , Germany
Internistische Gemeinschaftspraxis - Oldenburg, Oldenburg, , Germany
, Pforzheim, , Germany
Scherpunktpraxis fur Hematologie und Onkologie, Regensburg, , Germany
Krankenhaus Barmherzige Brueder Regensburg, Regensburg, , Germany
Schwerpunktpraxis fuer Haematologie und Onkologie, Saarbruecken, , Germany
St. Marien - Krankenhaus Siegen GMBH, Siegen, , Germany
Southwest German Cancer Center at Eberhard-Karls-University, Tuebingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm, , Germany
St. Marienhospital - Vechta, Vechta, , Germany
Haematologische Praxis, Weiden, , Germany
Helios Kliniken Wuppertal University Hospital, Wuppertal, , Germany
Hamatologisch - Onkologische Praxis Wurzburg, Wurzburg, , Germany
Contact Details
Name: Michael Hallek, MD
Affiliation: Medizinische Universitaetsklinik I at the University of Cologne
Role: STUDY_CHAIR
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