Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

May 31, 2008

Study Completion Date

October 31, 2010

Conditions
Chronic Lymphocytic LeukemiaAnemia
Interventions
BIOLOGICAL

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

DRUG

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."

Trial Locations (46)

13347

Internistische Gemeinschaftspraxis - Berlin, Berlin

22844

Praxis fuer Haematologie und Interne Onkologie, Norderstedt

37075

Universitaetsklinikum Göttingen, Göttingen

40211

Internistische Praxis - Dusseldorf, Düsseldorf

65812

Onkologische Schwerpunktpraxis und Tagesklinik Dres, Bad Soden

66113

Schwerpunktpraxis fuer Haematologie und Onkologie, Saarbrücken

66822

Caritas - Krakenhaus Lebach, Lebach

70839

Internistische Praxis - Gerlingen, Gerlingen

75179

Pforzheim

76133

Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe

81245

Hamatologie/Onkologie Praxisgemeinschaft - Muenchen, München

82110

Internistische Praxisgemeinschaft, Germering

84028

Internistische Praxis - Landshut, Landshut

86150

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg, Augsburg

93053

Scherpunktpraxis fur Hematologie und Onkologie, Regensburg

96317

Internistische Onkologische Praxis - Kronach, Kronach

97070

Hamatologisch - Onkologische Praxis Wurzburg, Würzburg

D-10117

Charite - Campus Charite Mitte, Berlin

D-44791

Augusta-Kranken-Anstalt gGmbH, Bochum

D-50924

Medizinische Universitaetsklinik I at the University of Cologne, Cologne

D-26721

Hans - Susemihl - Krankenhaus, Emden

D-45122

Universitaetsklinikum Essen, Essen

D-15236

Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder)

06110

Internistische Gemeinschaftspraxis - Halle, Halle

D-20246

University Medical Center Hamburg - Eppendorf, Hamburg

D-55743

Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein

D-67653

Westpfalz-Klinikum GmbH, Kaiserslautern

D-87439

Klinikum Kempten Oberallgaeu, Kempten

D-26789

Onkologische Schwerpunktpraxis - Leer, Leer

D-39130

Staedtisches Klinikum Magdeburg, Magdeburg

D-41063

Hospital Maria-Hilf II, Mönchengladbach

D-80335

Munich Oncologic Practice at Elisenhof, Munich

D-81377

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen, Munich

Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich

D-81679

Haematologische Schwerpunktpraxis, Munich

D-73557

Klinikum Schwaebisch Gmuend Stauferklinik, Mutlangen

D-81241

Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier, München

D-66538

Onkologische Schwerpunktpraxis Dr. Schmidt, Neunkirchen

D-26121

Internistische Gemeinschaftspraxis - Oldenburg, Oldenburg

D-93049

Krankenhaus Barmherzige Brueder Regensburg, Regensburg

D-57072

St. Marien - Krankenhaus Siegen GMBH, Siegen

D-72076

Southwest German Cancer Center at Eberhard-Karls-University, Tübingen

D-89081

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm

D-49377

St. Marienhospital - Vechta, Vechta

D-92637

Haematologische Praxis, Weiden

D-42283

Helios Kliniken Wuppertal University Hospital, Wuppertal

All Listed Sponsors
lead

German CLL Study Group

OTHER

NCT00281892 - Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter