Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

Last updated: February 18, 2020
Sponsor: German CLL Study Group
Overall Status: Completed

Phase

3

Condition

Platelet Disorders

Leukemia

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT00262782
CLL1
EU-20548
GCLLSG-138
MEDAC-GCLLSG-CLL1
  • Ages 18-75
  • All Genders

Study 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. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of B-cell chronic lymphocytic leukemia

  • Rai stage 0-II (Binet stage A) disease

  • Meets 1 of the following criteria:

  • High-risk disease, as defined by the following:

  • Serum thymidine kinase level > 7.0 U/L

  • Elevated β2-microglobulin level

  • Presence of non-nodular bone marrow infiltration

  • Short lymphocyte doubling time

  • Low-risk disease

  • Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • More than 6 months

Hematopoietic

  • No autoimmune hemolytic anemia

  • No thrombocytopenia

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No severe organ dysfunction

  • No other prior or concurrent malignancy

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

  • No other concurrent chemotherapy

Study Design

Total Participants: 877
Study Start date:
April 01, 1997
Estimated Completion Date:
June 30, 2010

Study Description

OBJECTIVES:

  • Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine.

  • Arm II: Patients undergo observation only.

PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Connect with a study center

  • Hanuschkrankenhaus

    Vienna, A-1140
    Austria

    Site Not Available

  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Wien, 1090
    Austria

    Site Not Available

  • Klinikum St. Marien

    Amberg, D-92224
    Germany

    Site Not Available

  • Internistische Praxis - Arnstadt

    Arnstadt, 99310
    Germany

    Site Not Available

  • Zentralklinikum Augsburg

    Augsburg, DOH-86156
    Germany

    Site Not Available

  • Kreiskrankenhaus Aurich

    Aurich, D-26603
    Germany

    Site Not Available

  • Regional Hospital Am Plattenwald

    Bad Friedrichshall, 74172
    Germany

    Site Not Available

  • Regional Hospital Bad Hersfeld

    Bad Hersfeld, 36251
    Germany

    Site Not Available

  • Arzt fuer Innere Medizin - Bad Reichenhall

    Bad Reichenhall, 83435
    Germany

    Site Not Available

  • Humaine - Clinic

    Bad Saarow, 15526
    Germany

    Site Not Available

  • Ermstalklinik Bad Urach

    Bad Urach, D-72574
    Germany

    Site Not Available

  • Charite - Campus Charite Mitte

    Berlin, D-10117
    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

  • Haematologisch-Onkologische Schwerpunktpraxis

    Berlin, 13357
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347
    Germany

    Site Not Available

  • Internistische Praxis - Berlin

    Berlin, 14052
    Germany

    Site Not Available

  • Gemeinschaftspraxis - Betzdorf

    Betzdorf, 57518
    Germany

    Site Not Available

  • Praxis Dres. F.& G. Doering

    Bremen, 28205
    Germany

    Site Not Available

  • Krankenhaus Burglengenfeld

    Burglengenfeld, 93133
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046
    Germany

    Site Not Available

  • Staedtisches Klinikum Dessau

    Dessau, D-06847
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis - Dresden

    Dresden, 01127
    Germany

    Site Not Available

  • Universitaetsklinik Duesseldorf

    Duesseldorf, D-40225
    Germany

    Site Not Available

  • Michael Schaefers und Partner

    Duisburg, D-47051
    Germany

    Site Not Available

  • Internistische Gemeinschaftpraxis - Ehingen

    Ehingen, 89584
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis - Erding

    Erding, 85435
    Germany

    Site Not Available

  • Internistische/Onkologische Praxis - Erfurt

    Erfurt, 99084
    Germany

    Site Not Available

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052
    Germany

    Site Not Available

  • St. Antonius Hospital

    Eschweiler, DOH-52249
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, D-45122
    Germany

    Site Not Available

  • Staedtische Kliniken Esslingen

    Esslingen, 73730
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Forchheim

    Forchheim, 91301
    Germany

    Site Not Available

  • Klinikum Garmisch - Partenkirchen

    Garmisch-Partenkirchen, N 82467
    Germany

    Site Not Available

  • Gemeinschaftspraxis - Germering

    Germering, 82110
    Germany

    Site Not Available

  • Internistische Praxisgemeinschaft

    Germering, 82110
    Germany

    Site Not Available

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis - Gross-Gerau

    Gross-Gerau, 64521
    Germany

    Site Not Available

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095
    Germany

    Site Not Available

  • St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH

    Hagen, 58095
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110
    Germany

    Site Not Available

  • Internistische Praxis - Halle

    Halle, 06108
    Germany

    Site Not Available

  • Martin Luther Universitaet

    Halle, D-06097
    Germany

    Site Not Available

  • Allgemeines Krankenhaus St. Georg

    Hamburg, D-20099
    Germany

    Site Not Available

  • Praxis fur Innere Medizin - Hamburg

    Hamburg, 22457
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246
    Germany

    Site Not Available

  • Schwerpunktpraxis Haematologie/Onkologie - Hannover

    Hannover, 30169
    Germany

    Site Not Available

  • Facharzt fuer Allgemeinmedizin - Hausham

    Hausham, 83734
    Germany

    Site Not Available

  • Facharzt fuer Innere Medizin - Hechingen

    Hechingen, 72379
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115
    Germany

    Site Not Available

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120
    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

  • Praxis am Evangelischen Krankenhaus Bethanien

    Iserlohn, D-58644
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Jena

    Jena, 07743
    Germany

    Site Not Available

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653
    Germany

    Site Not Available

  • Facharzt Fuer Jnnere Medizin

    Karlsruhe, 76135
    Germany

    Site Not Available

  • St. Vincentius-Kliniken

    Karlsruhe, D-76137
    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

  • Praxis Fuer Haematologie Internistische Onkologie

    Koeln, D-50677
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik I at the University of Cologne

    Koln, D-50924
    Germany

    Site Not Available

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317
    Germany

    Site Not Available

  • Internistische Praxis - Landshut

    Landshut, 84028
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis Leer

    Leer, D-26789
    Germany

    Site Not Available

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657
    Germany

    Site Not Available

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Mannheim, D-68161
    Germany

    Site Not Available

  • Philipps-Universitaet Marburg Klinikum

    Marburg, D-35033
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Memmingen

    Memmingen, 87700
    Germany

    Site Not Available

  • Klinikum Minden

    Minden, D-32427
    Germany

    Site Not Available

  • Haematologische Praxis - Moenchengladbach

    Moenchengladbach, 41239
    Germany

    Site Not Available

  • Haematologisch-onkologische Gemeinschaftspraxis - Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Hamatologische Schwerpunktpraxis

    Munich, 81679
    Germany

    Site Not Available

  • Klinikum Innenstadt

    Munich, 80331
    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

  • Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau

    Murnau, 82418
    Germany

    Site Not Available

  • Internistische Praxis - Neuenkirchen

    Neuenkirchen, 48485
    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

  • Sudharz-Krankenhaus Nordhausen gGmbH

    Nordhausen, 99734
    Germany

    Site Not Available

  • Klinikum Nuernberg - Klinikum Nord

    Nuernberg, D-90419
    Germany

    Site Not Available

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, 63065
    Germany

    Site Not Available

  • Hematologische Praxis

    Oldenburg, 26121
    Germany

    Site Not Available

  • Gemeinschaftliche Schwerpunktpraxis - Osnabrueck

    Osnabrueck, 49074
    Germany

    Site Not Available

  • Municipal Hospital Complex

    Pforzheim, D-75178
    Germany

    Site Not Available

  • Hematologische Onkologische Praxis

    Regensburg, 93047
    Germany

    Site Not Available

  • Jakobi Krankenhaus

    Rheine, 48431
    Germany

    Site Not Available

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057
    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

  • Onkologische Schwerpunktpraxis - Schrobenhausen

    Schrobenhausen, 86529
    Germany

    Site Not Available

  • Praxis - Schwenningen

    Schwenningen, 78054
    Germany

    Site Not Available

  • Evang. Jung-Stilling Hospital

    Siegen, D-57074
    Germany

    Site Not Available

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072
    Germany

    Site Not Available

  • Praxisgemeinschaft - Stade

    Stade, 21680
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis - Straubing

    Straubing, 94315
    Germany

    Site Not Available

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176
    Germany

    Site Not Available

  • Haematologische Praxis

    Stuttgart, D-70173
    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 - Weiden

    Weiden, 92637
    Germany

    Site Not Available

  • Haematologisch-Onkologische Schwerpunktpraxis - Weilheim

    Weilheim, 82362
    Germany

    Site Not Available

  • Internistische Praxis - Wendlingen

    Wendlingen, 73240
    Germany

    Site Not Available

  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

    Wuerzburg, D-97070
    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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