Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated 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: NCT00262795
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : May 15, 2018
Information provided by (Responsible Party):
German CLL Study Group

Brief 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.

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

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
Study Start Date : September 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : October 2005

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

Active Comparator: CLB
Drug: Chlorambucil
Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months


  • No thrombocytopenia
  • No autoimmune hemolytic anemia


  • Not specified


  • Not specified


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



  • 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): NCT00262795

  Hide Study Locations
Vienna, Austria, A-1140
Klinikum St. Marien
Amberg, Germany, D-92224
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany, 91522
Zentralklinikum Augsburg
Augsburg, Germany, DOH-86156
Humaine - Clinic
Bad Saarow, Germany, 15526
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, Germany, 95445
Onkologisches Versorgungszentrum Friedrichshain
Berlin, Germany, 10249
Internistische Gemeinschaftspraxis - Berlin
Berlin, Germany, 14195
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200
Charite - Campus Virchow Klinikum
Berlin, Germany, D-13353
Saint Josef - Hospital Bochum
Bochum, Germany, 44791
Praxis Dres. F.& G. Doering
Bremen, Germany, 28205
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
Onkologische Schwerpunktpraxis
Cottbus, Germany, D-03046
Onkologische Gemeinschaftspraxis - Dresden
Dresden, Germany, 01127
Krankenhaus Benrath
Dusseldorf, Germany, 40593
Hans - Susemihl - Krankenhaus
Emden, Germany, D-26721
Kreiskrankenhaus Erding
Erding, Germany, 85435
Internistische/Onkologische Praxis - Erfurt
Erfurt, Germany, 99084
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Onkologische Schwerpunkt Praxis
Erlangen, Germany, D-91052
Universitaetsklinikum Essen
Essen, Germany, D-45122
Evangelisches Krankenhaus Essen Werden
Essen, Germany, D-45239
Gemeinschaftspraxis - Freiburg
Freiburg, Germany, 79098
Klinikum Garmisch - Partenkirchen
Garmisch-Partenkirchen, Germany, N 82467
Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera
Gera, Germany, 07548
Internistische Praxis - Gerlingen
Gerlingen, Germany, 70839
Internistische Praxisgemeinschaft
Germering, Germany, 82110
Universitaetsklinikum Goettingen
Goettingen, Germany, D-37075
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
Gustrow, Germany, 18273
Internistische Praxis - Halle
Halle, Germany, 06108
Internistische Gemeinschaftspraxis - Halle
Halle, Germany, 06110
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, D-20246
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, Germany, D-59071
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hannover, Germany, 30169
Eichsfeld Klinikum gGmbH
Heiligenstadt, Germany, 37339
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
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany, D-67653
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, Germany, 76133
Internistische Gemeinschaftspraxis - Kassel
Kassel, Germany, 34117
Staedtische Krankenhaus Kiel
Kiel, Germany, 23116
Krankenhaus Maria-Hilf Krefeld
Krefeld, Germany, 47805
Internistische Onkologische Praxis - Kronach
Kronach, Germany, 96317
Internistische Praxis - Landshut
Landshut, Germany, 84028
Klinikum Lippe - Lemgo
Lemgo, Germany, D-32657
Internistische Praxis - Ludwigsburg
Ludwigsburg, Germany, 71638
Kreiskrankenhaus Luedenscheid
Luedenscheid, Germany, 58515
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68305
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
Muenster, Germany, 48149
Regional Hospital Munchberg
Munchber, Germany, D-95213
Hamatologie/Onkologie Praxisgemeinschaft - Munchen
Munchen, Germany, 81245
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 Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, Germany, D-66538
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, Germany, 22844
Praxisklinik fuer Innere Medizin - Nuernberg
Nuernberg, Germany, 90449
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Internistische Gemeinschaftspraxis - Oberstaufen
Oberstaufen, Germany, 87534
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, Germany, 63065
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, Germany, 26121
Klinikum Ernst Von Bergmann
Postdam, Germany, D-14467
Haematologische/Onkologische Schwerpunktpraxis - Rostock
Rostock, Germany, 18057
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, Germany, D-18057
Internistische Schwerpunktpraxis
Russelsheim, Germany, 65428
Caritasklinik St. Theresia
Saarbrucken, Germany, D-66113
Internistische Gemeinschaftspraxis - Saarbruecken
Saarbruecken, Germany, 66121
Schwerpunktpraxis Fuer Haematologie Und Onkologie
Saarbruecke, Germany, N-66113
Kliniken Landkreis Sigmaringen GMBH
Sigmaringen, Germany, D-72488
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, Germany, 70176
Marienhospital Stuttgart
Stuttgart, Germany, 70199
Haematologische Praxis
Stuttgart, Germany, D-70173
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, Germany, D-70174
Onkologische Gemeinschaftspraxis - Trier
Trier, Germany, 54290
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, Germany, D-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
Worms, Germany, DOH-67547
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:
Other Publications:
Responsible Party: German CLL Study Group Identifier: NCT00262795     History of Changes
Other Study ID Numbers: CLL5
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by German CLL Study Group:
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV 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
Antineoplastic Agents, Alkylating
Alkylating Agents