Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
- Conditions
- AnemiaChronic Lymphocytic Leukemia
- Interventions
- Biological: Fludarabine plus Darbopoetin
- Registration Number
- NCT00281892
- Lead Sponsor
- German CLL Study Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fludarabine mono Fludarabine mono Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support. Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa. Fludarabine plus Darbopoetin Fludarabine plus Darbopoetin Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
- Primary Outcome Measures
Name Time Method Event-free survival up to 24 months after the last dose of study medication defined as the time from initial randomization/stratification to the time-point of progressive disease, new therapy, or death)
- Secondary Outcome Measures
Name Time Method Response Rate 2 months after the end of the last cycle Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
toxicity 28 days after the end of the last cycle adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0).
Trial Locations
- Locations (45)
Caritas - Krakenhaus Lebach
🇩🇪Lebach, Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
🇩🇪Munich, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Scherpunktpraxis fur Hematologie und Onkologie
🇩🇪Regensburg, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany
Haematologische Praxis
🇩🇪Weiden, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis und Tagesklinik Dres
🇩🇪Bad Soden, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt (Oder), Germany
Internistische Praxis - Gerlingen
🇩🇪Gerlingen, Germany
Internistische Praxisgemeinschaft
🇩🇪Germering, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Staedtisches Klinikum Magdeburg
🇩🇪Magdeburg, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Internistische Praxis - Dusseldorf
🇩🇪Dusseldorf, Germany
Universitaetsklinikum Göttingen
🇩🇪Göttingen, Germany
Internistische Gemeinschaftspraxis - Halle
🇩🇪Halle, Germany
Klinikum Kempten Oberallgaeu
🇩🇪Kempten, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Hospital Maria-Hilf II
🇩🇪Monchengladbach, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
🇩🇪Munchen, Germany
Haematologische Schwerpunktpraxis
🇩🇪Munich, Germany
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Helios Kliniken Wuppertal University Hospital
🇩🇪Wuppertal, Germany
Augusta-Kranken-Anstalt gGmbH
🇩🇪Bochum, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munich, Germany
Klinikum Schwaebisch Gmuend Stauferklinik
🇩🇪Mutlangen, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
🇩🇪Augsburg, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Internistische Praxis - Landshut
🇩🇪Landshut, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, 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
Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier
🇩🇪München, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany