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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262782
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
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. 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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Fludarabine Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Study Start Date : April 1997
Actual Primary Completion Date : December 2004
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: Fludarabine Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other Name: Fludura

No Intervention: watch & wait

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Not specified

Life expectancy

  • More than 6 months


  • No autoimmune hemolytic anemia
  • No thrombocytopenia


  • Not specified


  • Not specified


  • No severe organ dysfunction
  • No other prior or concurrent malignancy



  • No prior chemotherapy
  • No other concurrent chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262782

  Hide Study Locations
Vienna, Austria, A-1140
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Wien, Austria, 1090
Klinikum St. Marien
Amberg, Germany, D-92224
Internistische Praxis - Arnstadt
Arnstadt, Germany, 99310
Zentralklinikum Augsburg
Augsburg, Germany, DOH-86156
Kreiskrankenhaus Aurich
Aurich, Germany, D-26603
Regional Hospital Am Plattenwald
Bad Friedrichshall, Germany, 74172
Regional Hospital Bad Hersfeld
Bad Hersfeld, Germany, 36251
Arzt fuer Innere Medizin - Bad Reichenhall
Bad Reichenhall, Germany, 83435
Humaine - Clinic
Bad Saarow, Germany, 15526
Ermstalklinik Bad Urach
Bad Urach, Germany, D-72574
Internistische Praxis - Berlin
Berlin, Germany, 10969
Internistische Gemeinschaftspraxis - Berlin
Berlin, Germany, 13347
Haematologisch-Onkologische Schwerpunktpraxis
Berlin, Germany, 13357
Internistische Praxis - Berlin
Berlin, Germany, 14052
Internistische Gemeinschaftspraxis - Berlin
Berlin, Germany, 14195
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200
Charite - Campus Virchow Klinikum
Berlin, Germany, D-13353
Gemeinschaftspraxis - Betzdorf
Betzdorf, Germany, 57518
Praxis Dres. F.& G. Doering
Bremen, Germany, 28205
Krankenhaus Burglengenfeld
Burglengenfeld, Germany, 93133
Onkologische Schwerpunktpraxis
Cottbus, Germany, D-03046
Staedtisches Klinikum Dessau
Dessau, Germany, D-06847
Onkologische Gemeinschaftspraxis - Dresden
Dresden, Germany, 01127
Universitaetsklinik Duesseldorf
Duesseldorf, Germany, D-40225
Michael Schaefers und Partner
Duisburg, Germany, D-47051
Internistische Gemeinschaftpraxis - Ehingen
Ehingen, Germany, 89584
Onkologische Schwerpunktpraxis - Erding
Erding, Germany, 85435
Internistische/Onkologische Praxis - Erfurt
Erfurt, Germany, 99084
Onkologische Schwerpunkt Praxis
Erlangen, Germany, D-91052
St. Antonius Hospital
Eschweiler, Germany, DOH-52249
Universitaetsklinikum Essen
Essen, Germany, D-45122
Staedtische Kliniken Esslingen
Esslingen, Germany, 73730
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, Germany, 91301
Klinikum Garmisch - Partenkirchen
Garmisch-Partenkirchen, Germany, N 82467
Gemeinschaftspraxis - Germering
Germering, Germany, 82110
Internistische Praxisgemeinschaft
Germering, Germany, 82110
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, D-17487
Onkologische Gemeinschaftspraxis - Gross-Gerau
Gross-Gerau, Germany, 64521
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH
Hagen, Germany, 58095
Allgemeines Krankenhaus Hagen
Hagen, Germany, D-58095
Internistische Praxis - Halle
Halle, Germany, 06108
Internistische Gemeinschaftspraxis - Halle
Halle, Germany, 06110
Martin Luther Universitaet
Halle, Germany, D-06097
Praxis fur Innere Medizin - Hamburg
Hamburg, Germany, 22457
Allgemeines Krankenhaus St. Georg
Hamburg, Germany, D-20099
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, D-20246
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hannover, Germany, 30169
Facharzt fuer Allgemeinmedizin - Hausham
Hausham, Germany, 83734
Facharzt fuer Innere Medizin - Hechingen
Hechingen, Germany, 72379
Onkologische Schwerpunktpraxis Heidelberg
Heidelberg, Germany, 69115
Universitatsklinikum Heidelberg
Heidelberg, Germany, 69120
Medizinischen Klinik Dr. R. Schindlbeck
Herrsching, Germany, 82211
Oncological Specialist Practice
Hildesheim, Germany, 31134
Universitaetsklinikum des Saarlandes
Homburg, Germany, D-66421
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, Germany, D-55743
Praxis am Evangelischen Krankenhaus Bethanien
Iserlohn, Germany, D-58644
Internistische Gemeinschaftspraxis - Jena
Jena, Germany, 07743
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany, D-67653
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, Germany, 76133
Facharzt Fuer Jnnere Medizin
Karlsruhe, Germany, 76135
St. Vincentius-Kliniken
Karlsruhe, Germany, D-76137
Internistische Gemeinschaftspraxis - Kassel
Kassel, Germany, 34117
Staedtische Krankenhaus Kiel
Kiel, Germany, 23116
Praxis Fuer Haematologie Internistische Onkologie
Koeln, Germany, D-50677
Medizinische Universitaetsklinik I at the University of Cologne
Koln, Germany, D-50924
Internistische Onkologische Praxis - Kronach
Kronach, Germany, 96317
Internistische Praxis - Landshut
Landshut, Germany, 84028
Onkologische Schwerpunktpraxis Leer
Leer, Germany, D-26789
Klinikum Lippe - Lemgo
Lemgo, Germany, D-32657
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, D-39120
Mannheim, Germany, D-68161
Philipps-Universitaet Marburg Klinikum
Marburg, Germany, D-35033
Internistische Gemeinschaftspraxis - Memmingen
Memmingen, Germany, 87700
Klinikum Minden
Minden, Germany, D-32427
Haematologische Praxis - Moenchengladbach
Moenchengladbach, Germany, 41239
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
Muenster, Germany, 48149
Klinikum Innenstadt
Munich, Germany, 80331
Krankenhaus Muenchen Schwabing
Munich, Germany, 80804
Hamatologische Schwerpunktpraxis
Munich, Germany, 81679
Munich Oncologic Practice at Elisenhof
Munich, Germany, D-80335
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, Germany, D-81545
Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau
Murnau, Germany, 82418
Internistische Praxis - Neuenkirchen
Neuenkirchen, Germany, 48485
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, Germany, D-66538
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, Germany, 22844
Sudharz-Krankenhaus Nordhausen gGmbH
Nordhausen, Germany, 99734
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, Germany, 63065
Hematologische Praxis
Oldenburg, Germany, 26121
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
Osnabrueck, Germany, 49074
Municipal Hospital Complex
Pforzheim, Germany, D-75178
Hematologische Onkologische Praxis
Regensburg, Germany, 93047
Jakobi Krankenhaus
Rheine, Germany, 48431
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, Germany, D-18057
Caritasklinik St. Theresia
Saarbrucken, Germany, D-66113
Schwerpunktpraxis Fuer Haematologie Und Onkologie
Saarbruecke, Germany, N-66113
Onkologische Schwerpunktpraxis - Schrobenhausen
Schrobenhausen, Germany, 86529
Praxis - Schwenningen
Schwenningen, Germany, 78054
St. Marien - Krankenhaus Siegen GMBH
Siegen, Germany, D-57072
Evang. Jung-Stilling Hospital
Siegen, Germany, D-57074
Praxisgemeinschaft - Stade
Stade, Germany, 21680
Onkologische Schwerpunktpraxis - Straubing
Straubing, Germany, 94315
Haematologische Praxis
Stuttgart, Germany, D-70173
Diakonie Klinikum Stuttgart
Stuttgart, Germany, D-70176
Onkologische Gemeinschaftspraxis - Trier
Trier, Germany, 54290
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Universitaetsklinikum Ulm
Ulm, Germany, D-89081
St. Marien Hospital
Vechta, Germany, D-49377
Gemeinschaftspraxis - Weiden
Weiden, Germany, 92637
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
Weilheim, Germany, 82362
Internistische Praxis - Wendlingen
Wendlingen, Germany, 73240
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, D-97070
Kliniken St. Antonius
Wuppertal 2, Germany, D-42283
Hamatologisch - Onkologische Praxis Wurzburg
Wurzburg, Germany, 97070
Sponsors and Collaborators
German CLL Study Group
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne

Additional Information:
Publications of Results:
Bergmann MA, Eichhorst BF, Busch R, et al.: Early and risk-adapted therapy with fludarabine in high-risk Binet stage A CLL patients prolongs progression free survival but not overall survival: results of the CLL1 protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.
Bergmann MA, Eichhorst BF, Busch R, et al.: Prospective evaluation of prognostic parameters in early stage chronic lymphocytic leukemia (CLL): results of the CLL1-protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-625, 2007.

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: German CLL Study Group Identifier: NCT00262782     History of Changes
Other Study ID Numbers: CLL1
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by German CLL Study Group:
B-cell chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents