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

NCT ID: NCT00262782

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 877 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-04-30
• Study Completion Date: 2010-06-30

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.

Detailed 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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fludarabine

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

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

watch & wait

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fludarabine

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

Intervention Type: DRUG

Other Intervention Names

Fludura

Eligibility Criteria

Inclusion Criteria

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 β2-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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German CLL Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hallek, MD

Role: STUDY_CHAIR

Medizinische Universitaetsklinik I at the University of Cologne

Locations

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

Vienna, , Austria

Hanuschkrankenhaus

Vienna, , Austria

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

Internistische Praxis - Berlin

Berlin, , Germany

Internistische Gemeinschaftspraxis - Berlin

Berlin, , Germany

Haematologisch-Onkologische Schwerpunktpraxis

Berlin, , Germany

Internistische Praxis - Berlin

Berlin, , Germany

Internistische Gemeinschaftspraxis - Berlin

Berlin, , Germany

Charite - Campus Charite Mitte

Berlin, , Germany

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, , Germany

Charite - Campus Virchow Klinikum

Berlin, , Germany

Gemeinschaftspraxis - Betzdorf

Betzdorf, , Germany

Praxis Dres. F.& G. Doering

Bremen, , Germany

Krankenhaus Burglengenfeld

Burglengenfeld, , Germany

Praxis Fuer Haematologie Internistische Onkologie

Cologne, , Germany

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, , Germany

Onkologische Schwerpunktpraxis

Cottbus, , Germany

Staedtisches Klinikum Dessau

Dessau, , Germany

Onkologische Gemeinschaftspraxis - Dresden

Dresden, , Germany

Michael Schaefers und Partner

Duisburg, , Germany

Universitaetsklinik Duesseldorf

Düsseldorf, , 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 am Neckar, , 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

St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH

Hagen, , Germany

Allgemeines Krankenhaus Hagen

Hagen, , Germany

Internistische Praxis - Halle

Halle, , Germany

Internistische Gemeinschaftspraxis - Halle

Halle, , Germany

Martin Luther Universitaet

Halle, , Germany

Praxis fur Innere Medizin - Hamburg

Hamburg, , Germany

Allgemeines Krankenhaus St. Georg

Hamburg, , Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Schwerpunktpraxis Haematologie/Onkologie - Hannover

Hanover, , 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 am Ammersee, , 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

Staedt Klinikum Karlsruhe GGMBH

Karlsruhe, , Germany

Facharzt Fuer Jnnere Medizin

Karlsruhe, , Germany

St. Vincentius-Kliniken

Karlsruhe, , Germany

Internistische Gemeinschaftspraxis - Kassel

Kassel, , Germany

Staedtische Krankenhaus Kiel

Kiel, , 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

Mönchengladbach, , Germany

Klinikum Innenstadt

Munich, , Germany

Krankenhaus Muenchen Schwabing

Munich, , Germany

Hamatologische Schwerpunktpraxis

Munich, , Germany

Munich Oncologic Practice at Elisenhof

Munich, , Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , Germany

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, , Germany

Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau

Murnau am Staffelsee, , Germany

Haematologisch-onkologische Gemeinschaftspraxis - Muenster

Münster, , 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

Nuremberg, , Germany

Internistische Gemeinschaftspraxis - Offenbach

Offenbach, , Germany

Hematologische Praxis

Oldenburg, , Germany

Gemeinschaftliche Schwerpunktpraxis - Osnabrueck

Osnabrück, , 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

Schwerpunktpraxis Fuer Haematologie Und Onkologie

Saarbruecke, , Germany

Caritasklinik St. Theresia

Saarbrücken, , Germany

Onkologische Schwerpunktpraxis - Schrobenhausen

Schrobenhausen, , Germany

Praxis - Schwenningen

Schwenningen, , Germany

St. Marien - Krankenhaus Siegen GMBH

Siegen, , Germany

Evang. Jung-Stilling Hospital

Siegen, , Germany

Praxisgemeinschaft - Stade

Stade, , Germany

Onkologische Schwerpunktpraxis - Straubing

Straubing, , Germany

Haematologische Praxis

Stuttgart, , Germany

Diakonie Klinikum Stuttgart

Stuttgart, , Germany

Onkologische Gemeinschaftspraxis - Trier

Trier, , Germany

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, , 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

Kliniken St. Antonius

Wuppertal, , Germany

Hamatologisch - Onkologische Praxis Wurzburg

Würzburg, , Germany

Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Countries

Austria; Germany

References

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Other Identifiers

EU-20548

Identifier Type: -

Identifier Source: secondary_id

GCLLSG-138

Identifier Type: -

Identifier Source: secondary_id

MEDAC-GCLLSG-CLL1

Identifier Type: -

Identifier Source: secondary_id

CLL1

Identifier Type: -

Identifier Source: org_study_id