Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Last updated: May 21, 2019
Sponsor: German CLL Study Group
Overall Status: Completed

Phase

3

Condition

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT00262795
CLL5
GCLLSG-73
MEDAC-GCLLSG-CLL5
EU-20557
  • Ages 65-79
  • All Genders

Study Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:

  • Binet stage A with B symptoms

  • Binet stage B or C, meeting 1 of the following criteria:

  • Rapid disease progression

  • Enlarged lymph nodes and organs

  • Severe B symptoms

  • Previously untreated disease

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • No thrombocytopenia

  • No autoimmune hemolytic anemia

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No severe organ dysfunction

  • No other prior or concurrent neoplasm

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

  • No other concurrent chemotherapy

Study Design

Total Participants: 206
Study Start date:
September 01, 2003
Estimated Completion Date:
October 31, 2005

Study Description

OBJECTIVES:

Primary

  • Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.

  • Compare the duration of remission in patients treated with these regimens.

Secondary

  • Compare the incidence of toxicity, especially infections, in patients treated with these regimens.

  • Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.

  • Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.

Connect with a study center

  • Hanuschkrankenhaus

    Vienna, A-1140
    Austria

    Site Not Available

  • Klinikum St. Marien

    Amberg, D-92224
    Germany

    Site Not Available

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522
    Germany

    Site Not Available

  • Zentralklinikum Augsburg

    Augsburg, DOH-86156
    Germany

    Site Not Available

  • Humaine - Clinic

    Bad Saarow, 15526
    Germany

    Site Not Available

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, 95445
    Germany

    Site Not Available

  • Charite - Campus Virchow Klinikum

    Berlin, D-13353
    Germany

    Site Not Available

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 14195
    Germany

    Site Not Available

  • Onkologisches Versorgungszentrum Friedrichshain

    Berlin, 10249
    Germany

    Site Not Available

  • Saint Josef - Hospital Bochum

    Bochum, 44791
    Germany

    Site Not Available

  • Praxis Dres. F.& G. Doering

    Bremen, 28205
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis - Dresden

    Dresden, 01127
    Germany

    Site Not Available

  • Krankenhaus Benrath

    Dusseldorf, 40593
    Germany

    Site Not Available

  • Hans - Susemihl - Krankenhaus

    Emden, D-26721
    Germany

    Site Not Available

  • Kreiskrankenhaus Erding

    Erding, 85435
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt, 99089
    Germany

    Site Not Available

  • Internistische/Onkologische Praxis - Erfurt

    Erfurt, 99084
    Germany

    Site Not Available

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, D-45122
    Germany

    Site Not Available

  • Gemeinschaftspraxis - Freiburg

    Freiburg, 79098
    Germany

    Site Not Available

  • Klinikum Garmisch - Partenkirchen

    Garmisch-Partenkirchen, N 82467
    Germany

    Site Not Available

  • Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera

    Gera, 07548
    Germany

    Site Not Available

  • Internistische Praxis - Gerlingen

    Gerlingen, 70839
    Germany

    Site Not Available

  • Internistische Praxisgemeinschaft

    Germering, 82110
    Germany

    Site Not Available

  • Universitaetsklinikum Goettingen

    Goettingen, D-37075
    Germany

    Site Not Available

  • Internistisch-Haematologische Gemeinschaftspraxis - Gustrow

    Gustrow, 18273
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110
    Germany

    Site Not Available

  • Internistische Praxis - Halle

    Halle, 06108
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246
    Germany

    Site Not Available

  • St. Marien-Hospital Hamm - Klinik Knappenstrasse

    Hamm, D-59071
    Germany

    Site Not Available

  • Schwerpunktpraxis Haematologie/Onkologie - Hannover

    Hannover, 30169
    Germany

    Site Not Available

  • Eichsfeld Klinikum gGmbH

    Heiligenstadt, 37339
    Germany

    Site Not Available

  • Medizinischen Klinik Dr. R. Schindlbeck

    Herrsching, 82211
    Germany

    Site Not Available

  • Oncological Specialist Practice

    Hildesheim, 31134
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421
    Germany

    Site Not Available

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743
    Germany

    Site Not Available

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653
    Germany

    Site Not Available

  • Staedt Klinikum Karlsruhe GGMBH

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, 34117
    Germany

    Site Not Available

  • Staedtische Krankenhaus Kiel

    Kiel, 23116
    Germany

    Site Not Available

  • Krankenhaus Maria-Hilf Krefeld

    Krefeld, 47805
    Germany

    Site Not Available

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317
    Germany

    Site Not Available

  • Internistische Praxis - Landshut

    Landshut, 84028
    Germany

    Site Not Available

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657
    Germany

    Site Not Available

  • Internistische Praxis - Ludwigsburg

    Ludwigsburg, 71638
    Germany

    Site Not Available

  • Kreiskrankenhaus Luedenscheid

    Luedenscheid, 58515
    Germany

    Site Not Available

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305
    Germany

    Site Not Available

  • Haematologisch-onkologische Gemeinschaftspraxis - Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Regional Hospital Munchberg

    Munchber, D-95213
    Germany

    Site Not Available

  • Hamatologie/Onkologie Praxisgemeinschaft - Munchen

    Munchen, 81245
    Germany

    Site Not Available

  • Hamatologische Schwerpunktpraxis

    Munich, 81679
    Germany

    Site Not Available

  • Klinikum Innenstadt

    Munich, 80331
    Germany

    Site Not Available

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675
    Germany

    Site Not Available

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377
    Germany

    Site Not Available

  • Krankenhaus Muenchen Schwabing

    Munich, 80804
    Germany

    Site Not Available

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335
    Germany

    Site Not Available

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538
    Germany

    Site Not Available

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844
    Germany

    Site Not Available

  • Klinikum Nuernberg - Klinikum Nord

    Nuernberg, D-90419
    Germany

    Site Not Available

  • Praxisklinik fuer Innere Medizin - Nuernberg

    Nuernberg, 90449
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Oberstaufen

    Oberstaufen, 87534
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, 63065
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, 26121
    Germany

    Site Not Available

  • Klinikum Ernst Von Bergmann

    Postdam, D-14467
    Germany

    Site Not Available

  • Haematologische/Onkologische Schwerpunktpraxis - Rostock

    Rostock, 18057
    Germany

    Site Not Available

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057
    Germany

    Site Not Available

  • Internistische Schwerpunktpraxis

    Russelsheim, 65428
    Germany

    Site Not Available

  • Caritasklinik St. Theresia

    Saarbrucken, D-66113
    Germany

    Site Not Available

  • Schwerpunktpraxis Fuer Haematologie Und Onkologie

    Saarbruecke, N-66113
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Saarbruecken

    Saarbruecken, 66121
    Germany

    Site Not Available

  • Kliniken Landkreis Sigmaringen GMBH

    Sigmaringen, D-72488
    Germany

    Site Not Available

  • Haematologische Praxis

    Stuttgart, D-70173
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Stuttgart

    Stuttgart, 70176
    Germany

    Site Not Available

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174
    Germany

    Site Not Available

  • Marienhospital Stuttgart

    Stuttgart, 70199
    Germany

    Site Not Available

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis - Trier

    Trier, 54290
    Germany

    Site Not Available

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tuebingen, D-72076
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, D-89081
    Germany

    Site Not Available

  • St. Marien Hospital

    Vechta, D-49377
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Worms, DOH-67547
    Germany

    Site Not Available

  • Kliniken St. Antonius

    Wuppertal 2, D-42283
    Germany

    Site Not Available

  • Hamatologisch - Onkologische Praxis Wurzburg

    Wurzburg, 97070
    Germany

    Site Not Available

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