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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262782
• Other study ID #: CLL1
• Secondary ID: EU-20548GCLLSG-1
• Status: Completed
• Phase: Phase 3
• Start date: April 1997
• Est. completion date: June 2010

Study information

• Verified date: February 2020
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: June 2010
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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 ß2-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

PATIENT CHARACTERISTICS:

Performance status

• Not specified

Life expectancy

• More than 6 months

Hematopoietic

• No autoimmune hemolytic anemia

• No thrombocytopenia

Hepatic

• Not specified

Renal

• Not specified

Other

• No severe organ dysfunction

• No other prior or concurrent malignancy

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles

Locations

Country	Name	City	State
Austria	Hanuschkrankenhaus	Vienna
Austria	Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik	Wien
Germany	Klinikum St. Marien	Amberg
Germany	Internistische Praxis - Arnstadt	Arnstadt
Germany	Zentralklinikum Augsburg	Augsburg
Germany	Kreiskrankenhaus Aurich	Aurich
Germany	Regional Hospital Am Plattenwald	Bad Friedrichshall
Germany	Regional Hospital Bad Hersfeld	Bad Hersfeld
Germany	Arzt fuer Innere Medizin - Bad Reichenhall	Bad Reichenhall
Germany	Humaine - Clinic	Bad Saarow
Germany	Ermstalklinik Bad Urach	Bad Urach
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Charite - Campus Virchow Klinikum	Berlin
Germany	Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	Haematologisch-Onkologische Schwerpunktpraxis	Berlin
Germany	Internistische Gemeinschaftspraxis - Berlin	Berlin
Germany	Internistische Gemeinschaftspraxis - Berlin	Berlin
Germany	Internistische Praxis - Berlin	Berlin
Germany	Internistische Praxis - Berlin	Berlin
Germany	Gemeinschaftspraxis - Betzdorf	Betzdorf
Germany	Praxis Dres. F.& G. Doering	Bremen
Germany	Krankenhaus Burglengenfeld	Burglengenfeld
Germany	Onkologische Schwerpunktpraxis	Cottbus
Germany	Staedtisches Klinikum Dessau	Dessau
Germany	Onkologische Gemeinschaftspraxis - Dresden	Dresden
Germany	Universitaetsklinik Duesseldorf	Duesseldorf
Germany	Michael Schaefers und Partner	Duisburg
Germany	Internistische Gemeinschaftpraxis - Ehingen	Ehingen
Germany	Onkologische Schwerpunktpraxis - Erding	Erding
Germany	Internistische/Onkologische Praxis - Erfurt	Erfurt
Germany	Onkologische Schwerpunkt Praxis	Erlangen
Germany	St. Antonius Hospital	Eschweiler
Germany	Universitaetsklinikum Essen	Essen
Germany	Staedtische Kliniken Esslingen	Esslingen
Germany	Internistische Gemeinschaftspraxis - Forchheim	Forchheim
Germany	Klinikum Garmisch - Partenkirchen	Garmisch-Partenkirchen
Germany	Gemeinschaftspraxis - Germering	Germering
Germany	Internistische Praxisgemeinschaft	Germering
Germany	Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet	Greifswald
Germany	Onkologische Gemeinschaftspraxis - Gross-Gerau	Gross-Gerau
Germany	Allgemeines Krankenhaus Hagen	Hagen
Germany	St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH	Hagen
Germany	Internistische Gemeinschaftspraxis - Halle	Halle
Germany	Internistische Praxis - Halle	Halle
Germany	Martin Luther Universitaet	Halle
Germany	Allgemeines Krankenhaus St. Georg	Hamburg
Germany	Praxis fur Innere Medizin - Hamburg	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Schwerpunktpraxis Haematologie/Onkologie - Hannover	Hannover
Germany	Facharzt fuer Allgemeinmedizin - Hausham	Hausham
Germany	Facharzt fuer Innere Medizin - Hechingen	Hechingen
Germany	Onkologische Schwerpunktpraxis Heidelberg	Heidelberg
Germany	Universitatsklinikum Heidelberg	Heidelberg
Germany	Medizinischen Klinik Dr. R. Schindlbeck	Herrsching
Germany	Oncological Specialist Practice	Hildesheim
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Clinic for Bone Marrow Transplantation and Hematology and Oncology	Idar-Oberstein
Germany	Praxis am Evangelischen Krankenhaus Bethanien	Iserlohn
Germany	Internistische Gemeinschaftspraxis - Jena	Jena
Germany	Westpfalz-Klinikum GmbH	Kaiserslautern
Germany	Facharzt Fuer Jnnere Medizin	Karlsruhe
Germany	St. Vincentius-Kliniken	Karlsruhe
Germany	Staedt Klinikum Karlsruhe GGMBH	Karlsruhe
Germany	Internistische Gemeinschaftspraxis - Kassel	Kassel
Germany	Staedtische Krankenhaus Kiel	Kiel
Germany	Praxis Fuer Haematologie Internistische Onkologie	Koeln
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Koln
Germany	Internistische Onkologische Praxis - Kronach	Kronach
Germany	Internistische Praxis - Landshut	Landshut
Germany	Onkologische Schwerpunktpraxis Leer	Leer
Germany	Klinikum Lippe - Lemgo	Lemgo
Germany	Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Germany	Gemeinschaftspraxis	Mannheim
Germany	Philipps-Universitaet Marburg Klinikum	Marburg
Germany	Internistische Gemeinschaftspraxis - Memmingen	Memmingen
Germany	Klinikum Minden	Minden
Germany	Haematologische Praxis - Moenchengladbach	Moenchengladbach
Germany	Haematologisch-onkologische Gemeinschaftspraxis - Muenster	Muenster
Germany	Hamatologische Schwerpunktpraxis	Munich
Germany	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich
Germany	Klinikum Innenstadt	Munich
Germany	Krankenhaus Muenchen Schwabing	Munich
Germany	Munich Oncologic Practice at Elisenhof	Munich
Germany	Staedtisches Krankenhaus Muenchen - Harlaching	Munich
Germany	Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau	Murnau
Germany	Internistische Praxis - Neuenkirchen	Neuenkirchen
Germany	Onkologische Schwerpunktpraxis Dr. Schmidt	Neunkirchen
Germany	Praxis fuer Haematologie und Interne Onkologie	Norderstedt
Germany	Sudharz-Krankenhaus Nordhausen gGmbH	Nordhausen
Germany	Klinikum Nuernberg - Klinikum Nord	Nuernberg
Germany	Internistische Gemeinschaftspraxis - Offenbach	Offenbach
Germany	Hematologische Praxis	Oldenburg
Germany	Gemeinschaftliche Schwerpunktpraxis - Osnabrueck	Osnabrueck
Germany	Municipal Hospital Complex	Pforzheim
Germany	Hematologische Onkologische Praxis	Regensburg
Germany	Jakobi Krankenhaus	Rheine
Germany	Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock	Rostock
Germany	Caritasklinik St. Theresia	Saarbrucken
Germany	Schwerpunktpraxis Fuer Haematologie Und Onkologie	Saarbruecke
Germany	Onkologische Schwerpunktpraxis - Schrobenhausen	Schrobenhausen
Germany	Praxis - Schwenningen	Schwenningen
Germany	Evang. Jung-Stilling Hospital	Siegen
Germany	St. Marien - Krankenhaus Siegen GMBH	Siegen
Germany	Praxisgemeinschaft - Stade	Stade
Germany	Onkologische Schwerpunktpraxis - Straubing	Straubing
Germany	Diakonie Klinikum Stuttgart	Stuttgart
Germany	Haematologische Praxis	Stuttgart
Germany	Onkologische Gemeinschaftspraxis - Trier	Trier
Germany	Southwest German Cancer Center at Eberhard-Karls-University	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Germany	St. Marien Hospital	Vechta
Germany	Gemeinschaftspraxis - Weiden	Weiden
Germany	Haematologisch-Onkologische Schwerpunktpraxis - Weilheim	Weilheim
Germany	Internistische Praxis - Wendlingen	Wendlingen
Germany	Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg	Wuerzburg
Germany	Kliniken St. Antonius	Wuppertal 2
Germany	Hamatologisch - Onkologische Praxis Wurzburg	Wurzburg

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (6)

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 (GC

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.

Göbel M, Eisele L, Möllmann M, Hüttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Döhner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Dührsen U, Dürig 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. — View Citation

Hoechstetter MA, Busch R, Eichhorst B, Bühler A, Winkler D, Bahlo J, Robrecht S, Eckart MJ, Vehling-Kaiser U, Jacobs G, Jäger U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Müller L, Goebeler M, Wendtner C, Fischer K, Herling — View Citation

Hoechstetter MA, Busch R, Eichhorst B, Bühler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jäger U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Müller L, Goebeler M, Wendtner CM, Bahlo J, Fischer K, Bentz M, Emmerich — View Citation

Sachanas 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. — View Citation

External Links

•   Click here for more information about this study: CLL1 (German CLL Study Group)