Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
4 other identifiers
interventional
206
2 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2003
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 6, 2005
CompletedFirst Posted
Study publicly available on registry
December 7, 2005
CompletedMay 23, 2019
May 1, 2019
1.3 years
December 6, 2005
May 21, 2019
Conditions
Keywords
Study Arms (2)
F
EXPERIMENTALFludarabine
CLB
ACTIVE COMPARATORChlorambucil
Interventions
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (88)
Hanuschkrankenhaus
Vienna, A-1140, Austria
Klinikum St. Marien
Amberg, D-92224, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, 91522, Germany
Zentralklinikum Augsburg
Augsburg, DOH-86156, Germany
Humaine - Clinic
Bad Saarow, 15526, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, 95445, Germany
Onkologisches Versorgungszentrum Friedrichshain
Berlin, 10249, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 14195, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Charite - Campus Virchow Klinikum
Berlin, D-13353, Germany
Saint Josef - Hospital Bochum
Bochum, 44791, Germany
Praxis Dres. F.& G. Doering
Bremen, 28205, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Onkologische Schwerpunktpraxis
Cottbus, D-03046, Germany
Onkologische Gemeinschaftspraxis - Dresden
Dresden, 01127, Germany
Krankenhaus Benrath
Düsseldorf, 40593, Germany
Hans - Susemihl - Krankenhaus
Emden, D-26721, Germany
Kreiskrankenhaus Erding
Erding, 85435, Germany
Internistische/Onkologische Praxis - Erfurt
Erfurt, 99084, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Onkologische Schwerpunkt Praxis
Erlangen, D-91052, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Evangelisches Krankenhaus Essen Werden
Essen, D-45239, Germany
Gemeinschaftspraxis - Freiburg
Freiburg im Breisgau, 79098, Germany
Klinikum Garmisch - Partenkirchen
Garmisch-Partenkirchen, N 82467, Germany
Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera
Gera, 07548, Germany
Internistische Praxis - Gerlingen
Gerlingen, 70839, Germany
Internistische Praxisgemeinschaft
Germering, 82110, Germany
Universitaetsklinikum Goettingen
Göttingen, D-37075, Germany
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
Güstrow, 18273, Germany
Internistische Praxis - Halle
Halle, 06108, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, 06110, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, D-20246, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, D-59071, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hanover, 30169, Germany
Eichsfeld Klinikum gGmbH
Heiligenstadt, 37339, Germany
Medizinischen Klinik Dr. R. Schindlbeck
Herrsching am Ammersee, 82211, Germany
Oncological Specialist Practice
Hildesheim, 31134, Germany
Universitaetsklinikum des Saarlandes
Homburg, D-66421, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, D-55743, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, 76133, Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, 34117, Germany
Staedtische Krankenhaus Kiel
Kiel, 23116, Germany
Krankenhaus Maria-Hilf Krefeld
Krefeld, 47805, Germany
Internistische Onkologische Praxis - Kronach
Kronach, 96317, Germany
Internistische Praxis - Landshut
Landshut, 84028, Germany
Klinikum Lippe - Lemgo
Lemgo, D-32657, Germany
Internistische Praxis - Ludwigsburg
Ludwigsburg, 71638, Germany
Kreiskrankenhaus Luedenscheid
Lüdenscheid, 58515, Germany
III Medizinische Klinik Mannheim
Mannheim, D-68305, Germany
Regional Hospital Munchberg
Munchber, D-95213, Germany
Klinikum Innenstadt
Munich, 80331, Germany
Krankenhaus Muenchen Schwabing
Munich, 80804, Germany
Hamatologische Schwerpunktpraxis
Munich, 81679, Germany
Munich Oncologic Practice at Elisenhof
Munich, D-80335, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, D-81545, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Munchen
München, 81245, Germany
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
Münster, 48149, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, D-66538, Germany
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, 22844, Germany
Praxisklinik fuer Innere Medizin - Nuernberg
Nuremberg, 90449, Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90419, Germany
Internistische Gemeinschaftspraxis - Oberstaufen
Oberstaufen, 87534, Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, 63065, Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, 26121, Germany
Klinikum Ernst Von Bergmann
Postdam, D-14467, Germany
Haematologische/Onkologische Schwerpunktpraxis - Rostock
Rostock, 18057, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, D-18057, Germany
Internistische Schwerpunktpraxis
Rüsselsheim am Main, 65428, Germany
Schwerpunktpraxis Fuer Haematologie Und Onkologie
Saarbruecke, N-66113, Germany
Internistische Gemeinschaftspraxis - Saarbruecken
Saarbrücken, 66121, Germany
Caritasklinik St. Theresia
Saarbrücken, D-66113, Germany
Kliniken Landkreis Sigmaringen GMBH
Sigmaringen, D-72488, Germany
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, 70176, Germany
Marienhospital Stuttgart
Stuttgart, 70199, Germany
Haematologische Praxis
Stuttgart, D-70173, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, D-70174, Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, 54290, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, D-54290, Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076, Germany
Universitaetsklinikum Ulm
Ulm, D-89081, Germany
St. Marien Hospital
Vechta, D-49377, Germany
Gemeinschaftspraxis
Worms, DOH-67547, Germany
Kliniken St. Antonius
Wuppertal, D-42283, Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, 97070, Germany
Related Publications (5)
Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.
PMID: 21139079BACKGROUNDCramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M. Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual. Leuk Res. 2014 Mar;38(3):284-5. doi: 10.1016/j.leukres.2013.11.015. Epub 2013 Dec 1. No abstract available.
PMID: 24412156BACKGROUNDGoede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Dohner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M; German CLL Study Group. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials. Haematologica. 2014 Jun;99(6):1095-100. doi: 10.3324/haematol.2013.096792. Epub 2014 Feb 28.
PMID: 24584349BACKGROUNDSachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.
PMID: 31092457BACKGROUNDEichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhofer N, Rohrberg R, Soling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Dohner H, Emmerich B, Hallek M; German CLL Study Group (GCLLSG). First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009 Oct 15;114(16):3382-91. doi: 10.1182/blood-2009-02-206185. Epub 2009 Jul 15.
PMID: 19605849RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2005
First Posted
December 7, 2005
Study Start
September 1, 2003
Primary Completion
January 1, 2005
Study Completion
October 1, 2005
Last Updated
May 23, 2019
Record last verified: 2019-05