Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
4 other identifiers
interventional
877
2 countries
117
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 1997
Longer than P75 for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 6, 2005
CompletedFirst Posted
Study publicly available on registry
December 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 20, 2020
February 1, 2020
7.7 years
December 6, 2005
February 18, 2020
Conditions
Keywords
Study Arms (2)
Fludarabine
EXPERIMENTALwatch & wait
NO INTERVENTIONInterventions
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (117)
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, 1090, Austria
Hanuschkrankenhaus
Vienna, A-1140, Austria
Klinikum St. Marien
Amberg, D-92224, Germany
Internistische Praxis - Arnstadt
Arnstadt, 99310, Germany
Zentralklinikum Augsburg
Augsburg, DOH-86156, Germany
Kreiskrankenhaus Aurich
Aurich, D-26603, Germany
Regional Hospital Am Plattenwald
Bad Friedrichshall, 74172, Germany
Regional Hospital Bad Hersfeld
Bad Hersfeld, 36251, Germany
Arzt fuer Innere Medizin - Bad Reichenhall
Bad Reichenhall, 83435, Germany
Humaine - Clinic
Bad Saarow, 15526, Germany
Ermstalklinik Bad Urach
Bad Urach, D-72574, Germany
Internistische Praxis - Berlin
Berlin, 10969, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 13347, Germany
Haematologisch-Onkologische Schwerpunktpraxis
Berlin, 13357, Germany
Internistische Praxis - Berlin
Berlin, 14052, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 14195, Germany
Charite - Campus Charite Mitte
Berlin, D-10117, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Charite - Campus Virchow Klinikum
Berlin, D-13353, Germany
Gemeinschaftspraxis - Betzdorf
Betzdorf, 57518, Germany
Praxis Dres. F.& G. Doering
Bremen, 28205, Germany
Krankenhaus Burglengenfeld
Burglengenfeld, 93133, Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Onkologische Schwerpunktpraxis
Cottbus, D-03046, Germany
Staedtisches Klinikum Dessau
Dessau, D-06847, Germany
Onkologische Gemeinschaftspraxis - Dresden
Dresden, 01127, Germany
Michael Schaefers und Partner
Duisburg, D-47051, Germany
Universitaetsklinik Duesseldorf
Düsseldorf, D-40225, Germany
Internistische Gemeinschaftpraxis - Ehingen
Ehingen, 89584, Germany
Onkologische Schwerpunktpraxis - Erding
Erding, 85435, Germany
Internistische/Onkologische Praxis - Erfurt
Erfurt, 99084, Germany
Onkologische Schwerpunkt Praxis
Erlangen, D-91052, Germany
St. Antonius Hospital
Eschweiler, DOH-52249, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, 73730, Germany
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, 91301, Germany
Klinikum Garmisch - Partenkirchen
Garmisch-Partenkirchen, N 82467, Germany
Gemeinschaftspraxis - Germering
Germering, 82110, Germany
Internistische Praxisgemeinschaft
Germering, 82110, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17487, Germany
Onkologische Gemeinschaftspraxis - Gross-Gerau
Groß-Gerau, 64521, Germany
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH
Hagen, 58095, Germany
Allgemeines Krankenhaus Hagen
Hagen, D-58095, Germany
Internistische Praxis - Halle
Halle, 06108, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, 06110, Germany
Martin Luther Universitaet
Halle, D-06097, Germany
Praxis fur Innere Medizin - Hamburg
Hamburg, 22457, Germany
Allgemeines Krankenhaus St. Georg
Hamburg, D-20099, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, D-20246, Germany
Schwerpunktpraxis Haematologie/Onkologie - Hannover
Hanover, 30169, Germany
Facharzt fuer Allgemeinmedizin - Hausham
Hausham, 83734, Germany
Facharzt fuer Innere Medizin - Hechingen
Hechingen, 72379, Germany
Onkologische Schwerpunktpraxis Heidelberg
Heidelberg, 69115, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, 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
Praxis am Evangelischen Krankenhaus Bethanien
Iserlohn, D-58644, Germany
Internistische Gemeinschaftspraxis - Jena
Jena, 07743, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, 76133, Germany
Facharzt Fuer Jnnere Medizin
Karlsruhe, 76135, Germany
St. Vincentius-Kliniken
Karlsruhe, D-76137, Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, 34117, Germany
Staedtische Krankenhaus Kiel
Kiel, 23116, Germany
Internistische Onkologische Praxis - Kronach
Kronach, 96317, Germany
Internistische Praxis - Landshut
Landshut, 84028, Germany
Onkologische Schwerpunktpraxis Leer
Leer, D-26789, Germany
Klinikum Lippe - Lemgo
Lemgo, D-32657, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, D-39120, Germany
Gemeinschaftspraxis
Mannheim, D-68161, Germany
Philipps-Universitaet Marburg Klinikum
Marburg, D-35033, Germany
Internistische Gemeinschaftspraxis - Memmingen
Memmingen, 87700, Germany
Klinikum Minden
Minden, D-32427, Germany
Haematologische Praxis - Moenchengladbach
Mönchengladbach, 41239, 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 Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau
Murnau am Staffelsee, 82418, Germany
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
Münster, 48149, Germany
Internistische Praxis - Neuenkirchen
Neuenkirchen, 48485, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, D-66538, Germany
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, 22844, Germany
Sudharz-Krankenhaus Nordhausen gGmbH
Nordhausen, 99734, Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90419, Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, 63065, Germany
Hematologische Praxis
Oldenburg, 26121, Germany
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
Osnabrück, 49074, Germany
Municipal Hospital Complex
Pforzheim, D-75178, Germany
Hematologische Onkologische Praxis
Regensburg, 93047, Germany
Jakobi Krankenhaus
Rheine, 48431, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, D-18057, Germany
Schwerpunktpraxis Fuer Haematologie Und Onkologie
Saarbruecke, N-66113, Germany
Caritasklinik St. Theresia
Saarbrücken, D-66113, Germany
Onkologische Schwerpunktpraxis - Schrobenhausen
Schrobenhausen, 86529, Germany
Praxis - Schwenningen
Schwenningen, 78054, Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072, Germany
Evang. Jung-Stilling Hospital
Siegen, D-57074, Germany
Praxisgemeinschaft - Stade
Stade, 21680, Germany
Onkologische Schwerpunktpraxis - Straubing
Straubing, 94315, Germany
Haematologische Praxis
Stuttgart, D-70173, Germany
Diakonie Klinikum Stuttgart
Stuttgart, D-70176, Germany
Onkologische Gemeinschaftspraxis - Trier
Trier, 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 - Weiden
Weiden, 92637, Germany
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
Weilheim, 82362, Germany
Internistische Praxis - Wendlingen
Wendlingen, 73240, Germany
Kliniken St. Antonius
Wuppertal, D-42283, Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, 97070, Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Würzburg, D-97070, Germany
Related Publications (10)
Gobel M, Eisele L, Mollmann M, Huttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Dohner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Duhrsen U, Durig J. Progranulin is a novel independent predictor of disease progression and overall survival in chronic lymphocytic leukemia. PLoS One. 2013 Aug 23;8(8):e72107. doi: 10.1371/journal.pone.0072107. eCollection 2013.
PMID: 24009671BACKGROUNDSachanas 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: 31092457BACKGROUNDBergmann 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.
RESULTBergmann 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.
RESULTHoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner CM, Bahlo J, Fischer K, Bentz M, Emmerich B, Dohner H, Hallek M, Stilgenbauer S. Early, risk-adapted treatment with fludarabine in Binet stage A chronic lymphocytic leukemia patients: results of the CLL1 trial of the German CLL study group. Leukemia. 2017 Dec;31(12):2833-2837. doi: 10.1038/leu.2017.246. Epub 2017 Aug 14. No abstract available.
PMID: 28804126RESULTHoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Bahlo J, Robrecht S, Eckart MJ, Vehling-Kaiser U, Jacobs G, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner C, Fischer K, Herling CD, Starck M, Bentz M, Emmerich B, Dohner H, Stilgenbauer S, Hallek M. Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group. Leukemia. 2020 Apr;34(4):1038-1051. doi: 10.1038/s41375-020-0727-y. Epub 2020 Feb 10.
PMID: 32042081RESULTLangerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.
PMID: 38620092DERIVEDJaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.
PMID: 33131249DERIVEDKreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.
PMID: 32735048DERIVEDPflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.
PMID: 24797299DERIVED
MeSH Terms
Conditions
Interventions
Condition 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
April 1, 1997
Primary Completion
December 1, 2004
Study Completion
June 1, 2010
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share