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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262795
• Other study ID #: CLL5
• Secondary ID: EU-20557MEDAC-GC
• Status: Completed
• Phase: Phase 3
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: May 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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

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
• Chlorambucil
Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Locations

Country	Name	City	State
Austria	Hanuschkrankenhaus	Vienna
Germany	Klinikum St. Marien	Amberg
Germany	Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie	Ansbach
Germany	Zentralklinikum Augsburg	Augsburg
Germany	Humaine - Clinic	Bad Saarow
Germany	Krankenhaus Hohe Warte Mediziniche Klinik	Bayreuth
Germany	Charite - Campus Virchow Klinikum	Berlin
Germany	Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	Internistische Gemeinschaftspraxis - Berlin	Berlin
Germany	Onkologisches Versorgungszentrum Friedrichshain	Berlin
Germany	Saint Josef - Hospital Bochum	Bochum
Germany	Praxis Dres. F.& G. Doering	Bremen
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Cologne
Germany	Onkologische Schwerpunktpraxis	Cottbus
Germany	Onkologische Gemeinschaftspraxis - Dresden	Dresden
Germany	Krankenhaus Benrath	Dusseldorf
Germany	Hans - Susemihl - Krankenhaus	Emden
Germany	Kreiskrankenhaus Erding	Erding
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Internistische/Onkologische Praxis - Erfurt	Erfurt
Germany	Onkologische Schwerpunkt Praxis	Erlangen
Germany	Evangelisches Krankenhaus Essen Werden	Essen
Germany	Universitaetsklinikum Essen	Essen
Germany	Gemeinschaftspraxis - Freiburg	Freiburg
Germany	Klinikum Garmisch - Partenkirchen	Garmisch-Partenkirchen
Germany	Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera	Gera
Germany	Internistische Praxis - Gerlingen	Gerlingen
Germany	Internistische Praxisgemeinschaft	Germering
Germany	Universitaetsklinikum Goettingen	Goettingen
Germany	Internistisch-Haematologische Gemeinschaftspraxis - Gustrow	Gustrow
Germany	Internistische Gemeinschaftspraxis - Halle	Halle
Germany	Internistische Praxis - Halle	Halle
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	St. Marien-Hospital Hamm - Klinik Knappenstrasse	Hamm
Germany	Schwerpunktpraxis Haematologie/Onkologie - Hannover	Hannover
Germany	Eichsfeld Klinikum gGmbH	Heiligenstadt
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	Westpfalz-Klinikum GmbH	Kaiserslautern
Germany	Staedt Klinikum Karlsruhe GGMBH	Karlsruhe
Germany	Internistische Gemeinschaftspraxis - Kassel	Kassel
Germany	Staedtische Krankenhaus Kiel	Kiel
Germany	Krankenhaus Maria-Hilf Krefeld	Krefeld
Germany	Internistische Onkologische Praxis - Kronach	Kronach
Germany	Internistische Praxis - Landshut	Landshut
Germany	Klinikum Lippe - Lemgo	Lemgo
Germany	Internistische Praxis - Ludwigsburg	Ludwigsburg
Germany	Kreiskrankenhaus Luedenscheid	Luedenscheid
Germany	III Medizinische Klinik Mannheim	Mannheim
Germany	Haematologisch-onkologische Gemeinschaftspraxis - Muenster	Muenster
Germany	Regional Hospital Munchberg	Munchber
Germany	Hamatologie/Onkologie Praxisgemeinschaft - Munchen	Munchen
Germany	Hamatologische Schwerpunktpraxis	Munich
Germany	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich
Germany	Klinikum Innenstadt	Munich
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich
Germany	Krankenhaus Muenchen Schwabing	Munich
Germany	Munich Oncologic Practice at Elisenhof	Munich
Germany	Staedtisches Krankenhaus Muenchen - Harlaching	Munich
Germany	Onkologische Schwerpunktpraxis Dr. Schmidt	Neunkirchen
Germany	Praxis fuer Haematologie und Interne Onkologie	Norderstedt
Germany	Klinikum Nuernberg - Klinikum Nord	Nuernberg
Germany	Praxisklinik fuer Innere Medizin - Nuernberg	Nuernberg
Germany	Internistische Gemeinschaftspraxis - Oberstaufen	Oberstaufen
Germany	Internistische Gemeinschaftspraxis - Offenbach	Offenbach
Germany	Internistische Gemeinschaftspraxis - Oldenburg	Oldenburg
Germany	Klinikum Ernst Von Bergmann	Postdam
Germany	Haematologische/Onkologische Schwerpunktpraxis - Rostock	Rostock
Germany	Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock	Rostock
Germany	Internistische Schwerpunktpraxis	Russelsheim
Germany	Caritasklinik St. Theresia	Saarbrucken
Germany	Schwerpunktpraxis Fuer Haematologie Und Onkologie	Saarbruecke
Germany	Internistische Gemeinschaftspraxis - Saarbruecken	Saarbruecken
Germany	Kliniken Landkreis Sigmaringen GMBH	Sigmaringen
Germany	Haematologische Praxis	Stuttgart
Germany	Internistische Gemeinschaftspraxis - Stuttgart	Stuttgart
Germany	Klinik fuer Onkologie - Katharinenhospital Stuttgart	Stuttgart
Germany	Marienhospital Stuttgart	Stuttgart
Germany	Krankenanstalt Mutterhaus der Borromaerinnen	Trier
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	Worms
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 (5)

Cramer 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. — View Citation

Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhöfer N, Rohrberg R, Söling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Döhner H, Emmerich B, Hallek M; German CLL Study — View Citation

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. — View Citation

Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Döhner 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. — 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: CLL5 (German CLL Study Group)