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

May 21, 2019 updated by: German CLL Study Group

Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1140
        • Hanuschkrankenhaus
  • Germany
      • Amberg, Germany, D-92224
        • Klinikum St. Marien
      • Ansbach, Germany, 91522
        • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
      • Augsburg, Germany, DOH-86156
        • Zentralklinikum Augsburg
      • Bad Saarow, Germany, 15526
        • Humaine - Clinic
      • Bayreuth, Germany, 95445
        • Krankenhaus Hohe Warte Mediziniche Klinik
      • Berlin, Germany, D-12200
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Berlin, Germany, 14195
        • Internistische Gemeinschaftspraxis - Berlin
      • Berlin, Germany, D-13353
        • Charité - Campus Virchow Klinikum
      • Berlin, Germany, 10249
        • Onkologisches Versorgungszentrum Friedrichshain
      • Bochum, Germany, 44791
        • Saint Josef - Hospital Bochum
      • Bremen, Germany, 28205
        • Praxis Dres. F.& G. Doering
      • Cologne, Germany, D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
      • Cottbus, Germany, D-03046
        • Onkologische Schwerpunktpraxis
      • Dresden, Germany, 01127
        • Onkologische Gemeinschaftspraxis - Dresden
      • Dusseldorf, Germany, 40593
        • Krankenhaus Benrath
      • Emden, Germany, D-26721
        • Hans - Susemihl - Krankenhaus
      • Erding, Germany, 85435
        • Kreiskrankenhaus Erding
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Erfurt, Germany, 99084
        • Internistische/Onkologische Praxis - Erfurt
      • Erlangen, Germany, D-91052
        • Onkologische Schwerpunkt Praxis
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Essen, Germany, D-45239
        • Evangelisches Krankenhaus Essen Werden
      • Freiburg, Germany, 79098
        • Gemeinschaftspraxis - Freiburg
      • Garmisch-Partenkirchen, Germany, N 82467
        • Klinikum Garmisch - Partenkirchen
      • Gera, Germany, 07548
        • Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera
      • Gerlingen, Germany, 70839
        • Internistische Praxis - Gerlingen
      • Germering, Germany, 82110
        • Internistische Praxisgemeinschaft
      • Goettingen, Germany, D-37075
        • Universitaetsklinikum Goettingen
      • Gustrow, Germany, 18273
        • Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
      • Halle, Germany, 06110
        • Internistische Gemeinschaftspraxis - Halle
      • Halle, Germany, 06108
        • Internistische Praxis - Halle
      • Hamburg, Germany, D-20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Hamm, Germany, D-59071
        • St. Marien-Hospital Hamm - Klinik Knappenstrasse
      • Hannover, Germany, 30169
        • Schwerpunktpraxis Haematologie/Onkologie - Hannover
      • Heiligenstadt, Germany, 37339
        • Eichsfeld Klinikum gGmbH
      • Herrsching, Germany, 82211
        • Medizinischen Klinik Dr. R. Schindlbeck
      • Hildesheim, Germany, 31134
        • Oncological Specialist Practice
      • Homburg, Germany, D-66421
        • Universitaetsklinikum des Saarlandes
      • Idar-Oberstein, Germany, D-55743
        • Clinic for Bone Marrow Transplantation and Hematology and Oncology
      • Kaiserslautern, Germany, D-67653
        • Westpfalz-Klinikum GmbH
      • Karlsruhe, Germany, 76133
        • Staedt Klinikum Karlsruhe GGMBH
      • Kassel, Germany, 34117
        • Internistische Gemeinschaftspraxis - Kassel
      • Kiel, Germany, 23116
        • Staedtische Krankenhaus Kiel
      • Krefeld, Germany, 47805
        • Krankenhaus Maria-Hilf Krefeld
      • Kronach, Germany, 96317
        • Internistische Onkologische Praxis - Kronach
      • Landshut, Germany, 84028
        • Internistische Praxis - Landshut
      • Lemgo, Germany, D-32657
        • Klinikum Lippe - Lemgo
      • Ludwigsburg, Germany, 71638
        • Internistische Praxis - Ludwigsburg
      • Luedenscheid, Germany, 58515
        • Kreiskrankenhaus Luedenscheid
      • Mannheim, Germany, D-68305
        • III Medizinische Klinik Mannheim
      • Muenster, Germany, 48149
        • Haematologisch-onkologische Gemeinschaftspraxis - Muenster
      • Munchber, Germany, D-95213
        • Regional Hospital Munchberg
      • Munchen, Germany, 81245
        • Hamatologie/Onkologie Praxisgemeinschaft - Munchen
      • Munich, Germany, D-81377
        • Klinikum der Universitaet Muenchen - Grosshadern Campus
      • Munich, Germany, 80804
        • Krankenhaus Muenchen Schwabing
      • Munich, Germany, D-81675
        • Klinikum Rechts der Isar - Technische Universitaet Muenchen
      • Munich, Germany, 80331
        • Klinikum Innenstadt
      • Munich, Germany, 81679
        • Hamatologische Schwerpunktpraxis
      • Munich, Germany, D-80335
        • Munich Oncologic Practice at Elisenhof
      • Munich, Germany, D-81545
        • Staedtisches Krankenhaus Muenchen - Harlaching
      • Neunkirchen, Germany, D-66538
        • Onkologische Schwerpunktpraxis Dr. Schmidt
      • Norderstedt, Germany, 22844
        • Praxis fuer Haematologie und Interne Onkologie
      • Nuernberg, Germany, D-90419
        • Klinikum Nuernberg - Klinikum Nord
      • Nuernberg, Germany, 90449
        • Praxisklinik fuer Innere Medizin - Nuernberg
      • Oberstaufen, Germany, 87534
        • Internistische Gemeinschaftspraxis - Oberstaufen
      • Offenbach, Germany, 63065
        • Internistische Gemeinschaftspraxis - Offenbach
      • Oldenburg, Germany, 26121
        • Internistische Gemeinschaftspraxis - Oldenburg
      • Postdam, Germany, D-14467
        • Klinikum Ernst von Bergmann
      • Rostock, Germany, D-18057
        • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
      • Rostock, Germany, 18057
        • Haematologische/Onkologische Schwerpunktpraxis - Rostock
      • Russelsheim, Germany, 65428
        • Internistische Schwerpunktpraxis
      • Saarbrucken, Germany, D-66113
        • Caritasklinik St. Theresia
      • Saarbruecke, Germany, N-66113
        • Schwerpunktpraxis fuer Haematologie und Onkologie
      • Saarbruecken, Germany, 66121
        • Internistische Gemeinschaftspraxis - Saarbruecken
      • Sigmaringen, Germany, D-72488
        • Kliniken Landkreis Sigmaringen GmbH
      • Stuttgart, Germany, D-70174
        • Klinik fuer Onkologie - Katharinenhospital Stuttgart
      • Stuttgart, Germany, D-70173
        • Haematologische Praxis
      • Stuttgart, Germany, 70199
        • Marienhospital Stuttgart
      • Stuttgart, Germany, 70176
        • Internistische Gemeinschaftspraxis - Stuttgart
      • Trier, Germany, D-54290
        • Krankenanstalt Mutterhaus der Borromaerinnen
      • Trier, Germany, 54290
        • Onkologische Gemeinschaftspraxis - Trier
      • Tuebingen, Germany, D-72076
        • Southwest German Cancer Center at Eberhard-Karls-University
      • Ulm, Germany, D-89081
        • Universitaetsklinikum Ulm
      • Vechta, Germany, D-49377
        • St. Marien Hospital
      • Worms, Germany, DOH-67547
        • Gemeinschaftspraxis
      • Wuppertal 2, Germany, D-42283
        • Kliniken St. Antonius
      • Wurzburg, Germany, 97070
        • Hamatologisch - Onkologische Praxis Wurzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: F
Fludarabine
Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Active Comparator: CLB
Chlorambucil
Drug: Chlorambucil
Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German CLL Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL5
  • EU-20557
  • MEDAC-GCLLSG-CLL5
  • GCLLSG-73

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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