Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
German CLL Study Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262782
First received: December 6, 2005
Last updated: July 23, 2008
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: fludarabine phosphate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | April 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262782
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| Austria | |
| Hanuschkrankenhaus | |
| Vienna, Austria, A-1140 | |
| Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik | |
| Wien, Austria, 1090 | |
| Germany | |
| Klinikum St. Marien | |
| Amberg, Germany, D-92224 | |
| Internistische Praxis - Arnstadt | |
| Arnstadt, Germany, 99310 | |
| Zentralklinikum Augsburg | |
| Augsburg, Germany, DOH-86156 | |
| Kreiskrankenhaus Aurich | |
| Aurich, Germany, D-26603 | |
| Regional Hospital Am Plattenwald | |
| Bad Friedrichshall, Germany, 74172 | |
| Regional Hospital Bad Hersfeld | |
| Bad Hersfeld, Germany, 36251 | |
| Arzt fuer Innere Medizin - Bad Reichenhall | |
| Bad Reichenhall, Germany, 83435 | |
| Humaine - Clinic | |
| Bad Saarow, Germany, 15526 | |
| Ermstalklinik Bad Urach | |
| Bad Urach, Germany, D-72574 | |
| Internistische Gemeinschaftspraxis - Berlin | |
| Berlin, Germany, 14195 | |
| Internistische Gemeinschaftspraxis - Berlin | |
| Berlin, Germany, 13347 | |
| Haematologisch-Onkologische Schwerpunktpraxis | |
| Berlin, Germany, 13357 | |
| Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | |
| Berlin, Germany, D-12200 | |
| Internistische Praxis - Berlin | |
| Berlin, Germany, 10969 | |
| Internistische Praxis - Berlin | |
| Berlin, Germany, 14052 | |
| Charite - Campus Charite Mitte | |
| Berlin, Germany, D-10117 | |
| Charite - Campus Virchow Klinikum | |
| Berlin, Germany, D-13353 | |
| Gemeinschaftspraxis - Betzdorf | |
| Betzdorf, Germany, 57518 | |
| Praxis Dres. F.& G. Doering | |
| Bremen, Germany, 28205 | |
| Krankenhaus Burglengenfeld | |
| Burglengenfeld, Germany, 93133 | |
| Onkologische Schwerpunktpraxis | |
| Cottbus, Germany, D-03046 | |
| Staedtisches Klinikum Dessau | |
| Dessau, Germany, D-06847 | |
| Onkologische Gemeinschaftspraxis - Dresden | |
| Dresden, Germany, 01127 | |
| Universitaetsklinik Duesseldorf | |
| Duesseldorf, Germany, D-40225 | |
| Michael Schaefers und Partner | |
| Duisburg, Germany, D-47051 | |
| Internistische Gemeinschaftpraxis - Ehingen | |
| Ehingen, Germany, 89584 | |
| Onkologische Schwerpunktpraxis - Erding | |
| Erding, Germany, 85435 | |
| Internistische/Onkologische Praxis - Erfurt | |
| Erfurt, Germany, 99084 | |
| Onkologische Schwerpunkt Praxis | |
| Erlangen, Germany, D-91052 | |
| St. Antonius Hospital | |
| Eschweiler, Germany, DOH-52249 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Staedtische Kliniken Esslingen | |
| Esslingen, Germany, 73730 | |
| Internistische Gemeinschaftspraxis - Forchheim | |
| Forchheim, Germany, 91301 | |
| Klinikum Garmisch - Partenkirchen | |
| Garmisch-Partenkirchen, Germany, N 82467 | |
| Gemeinschaftspraxis - Germering | |
| Germering, Germany, 82110 | |
| Internistische Praxisgemeinschaft | |
| Germering, Germany, 82110 | |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | |
| Greifswald, Germany, D-17487 | |
| Onkologische Gemeinschaftspraxis - Gross-Gerau | |
| Gross-Gerau, Germany, 64521 | |
| Allgemeines Krankenhaus Hagen | |
| Hagen, Germany, D-58095 | |
| St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH | |
| Hagen, Germany, 58095 | |
| Internistische Gemeinschaftspraxis - Halle | |
| Halle, Germany, 06110 | |
| Martin Luther Universitaet | |
| Halle, Germany, D-06097 | |
| Internistische Praxis - Halle | |
| Halle, Germany, 06108 | |
| Praxis fur Innere Medizin - Hamburg | |
| Hamburg, Germany, 22457 | |
| Allgemeines Krankenhaus St. Georg | |
| Hamburg, Germany, D-20099 | |
| Universitaetsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Schwerpunktpraxis Haematologie/Onkologie - Hannover | |
| Hannover, Germany, 30169 | |
| Facharzt fuer Allgemeinmedizin - Hausham | |
| Hausham, Germany, 83734 | |
| Facharzt fuer Innere Medizin - Hechingen | |
| Hechingen, Germany, 72379 | |
| Onkologische Schwerpunktpraxis Heidelberg | |
| Heidelberg, Germany, 69115 | |
| Universitatsklinikum Heidelberg | |
| Heidelberg, Germany, 69120 | |
| Medizinischen Klinik Dr. R. Schindlbeck | |
| Herrsching, Germany, 82211 | |
| Oncological Specialist Practice | |
| Hildesheim, Germany, 31134 | |
| Universitaetsklinikum des Saarlandes | |
| Homburg, Germany, D-66421 | |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | |
| Idar-Oberstein, Germany, D-55743 | |
| Praxis am Evangelischen Krankenhaus Bethanien | |
| Iserlohn, Germany, D-58644 | |
| Internistische Gemeinschaftspraxis - Jena | |
| Jena, Germany, 07743 | |
| Westpfalz-Klinikum GmbH | |
| Kaiserslautern, Germany, D-67653 | |
| Staedt Klinikum Karlsruhe GGMBH | |
| Karlsruhe, Germany, 76133 | |
| St. Vincentius-Kliniken | |
| Karlsruhe, Germany, D-76137 | |
| Facharzt Fuer Jnnere Medizin | |
| Karlsruhe, Germany, 76135 | |
| Internistische Gemeinschaftspraxis - Kassel | |
| Kassel, Germany, 34117 | |
| Staedtische Krankenhaus Kiel | |
| Kiel, Germany, 23116 | |
| Praxis Fuer Haematologie Internistische Onkologie | |
| Koeln, Germany, D-50677 | |
| Medizinische Universitaetsklinik I at the University of Cologne | |
| Koln, Germany, D-50924 | |
| Internistische Onkologische Praxis - Kronach | |
| Kronach, Germany, 96317 | |
| Internistische Praxis - Landshut | |
| Landshut, Germany, 84028 | |
| Onkologische Schwerpunktpraxis Leer | |
| Leer, Germany, D-26789 | |
| Klinikum Lippe - Lemgo | |
| Lemgo, Germany, D-32657 | |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| Gemeinschaftspraxis | |
| Mannheim, Germany, D-68161 | |
| Philipps-Universitaet Marburg Klinikum | |
| Marburg, Germany, D-35033 | |
| Internistische Gemeinschaftspraxis - Memmingen | |
| Memmingen, Germany, 87700 | |
| Klinikum Minden | |
| Minden, Germany, D-32427 | |
| Haematologische Praxis - Moenchengladbach | |
| Moenchengladbach, Germany, 41239 | |
| Haematologisch-onkologische Gemeinschaftspraxis - Muenster | |
| Muenster, Germany, 48149 | |
| Munich Oncologic Practice at Elisenhof | |
| Munich, Germany, D-80335 | |
| Staedtisches Krankenhaus Muenchen - Harlaching | |
| Munich, Germany, D-81545 | |
| Hamatologische Schwerpunktpraxis | |
| Munich, Germany, 81679 | |
| Klinikum Innenstadt | |
| Munich, Germany, 80331 | |
| Krankenhaus Muenchen Schwabing | |
| Munich, Germany, 80804 | |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | |
| Munich, Germany, D-81377 | |
| Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau | |
| Murnau, Germany, 82418 | |
| Internistische Praxis - Neuenkirchen | |
| Neuenkirchen, Germany, 48485 | |
| Onkologische Schwerpunktpraxis Dr. Schmidt | |
| Neunkirchen, Germany, D-66538 | |
| Praxis fuer Haematologie und Interne Onkologie | |
| Norderstedt, Germany, 22844 | |
| Sudharz-Krankenhaus Nordhausen gGmbH | |
| Nordhausen, Germany, 99734 | |
| Klinikum Nuernberg - Klinikum Nord | |
| Nuernberg, Germany, D-90419 | |
| Internistische Gemeinschaftspraxis - Offenbach | |
| Offenbach, Germany, 63065 | |
| Hematologische Praxis | |
| Oldenburg, Germany, 26121 | |
| Gemeinschaftliche Schwerpunktpraxis - Osnabrueck | |
| Osnabrueck, Germany, 49074 | |
| Municipal Hospital Complex | |
| Pforzheim, Germany, D-75178 | |
| Hematologische Onkologische Praxis | |
| Regensburg, Germany, 93047 | |
| Jakobi Krankenhaus | |
| Rheine, Germany, 48431 | |
| Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock | |
| Rostock, Germany, D-18057 | |
| Caritasklinik St. Theresia | |
| Saarbrucken, Germany, D-66113 | |
| Schwerpunktpraxis Fuer Haematologie Und Onkologie | |
| Saarbruecke, Germany, N-66113 | |
| Onkologische Schwerpunktpraxis - Schrobenhausen | |
| Schrobenhausen, Germany, 86529 | |
| Praxis - Schwenningen | |
| Schwenningen, Germany, 78054 | |
| St. Marien - Krankenhaus Siegen GMBH | |
| Siegen, Germany, D-57072 | |
| Evang. Jung-Stilling Hospital | |
| Siegen, Germany, D-57074 | |
| Praxisgemeinschaft - Stade | |
| Stade, Germany, 21680 | |
| Onkologische Schwerpunktpraxis - Straubing | |
| Straubing, Germany, 94315 | |
| Diakonie Klinikum Stuttgart | |
| Stuttgart, Germany, D-70176 | |
| Haematologische Praxis | |
| Stuttgart, Germany, D-70173 | |
| Onkologische Gemeinschaftspraxis - Trier | |
| Trier, Germany, 54290 | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| Universitaetsklinikum Ulm | |
| Ulm, Germany, D-89081 | |
| St. Marien Hospital | |
| Vechta, Germany, D-49377 | |
| Gemeinschaftspraxis - Weiden | |
| Weiden, Germany, 92637 | |
| Haematologisch-Onkologische Schwerpunktpraxis - Weilheim | |
| Weilheim, Germany, 82362 | |
| Internistische Praxis - Wendlingen | |
| Wendlingen, Germany, 73240 | |
| Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg | |
| Wuerzburg, Germany, D-97070 | |
| Kliniken St. Antonius | |
| Wuppertal 2, Germany, D-42283 | |
| Hamatologisch - Onkologische Praxis Wurzburg | |
| Wurzburg, Germany, 97070 | |
Sponsors and Collaborators
German CLL Study Group
Investigators
| Study Chair: | Michael Hallek, MD | Medizinische Universitaetsklinik I at the University of Cologne |
More Information
Additional Information:
Publications:
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 (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.
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.
| ClinicalTrials.gov Identifier: | NCT00262782 History of Changes |
| Other Study ID Numbers: | CDR0000455035, GCLLSG-CLL1, EU-20548, GCLLSG-138, MEDAC-GCLLSG-CLL1 |
| Study First Received: | December 6, 2005 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate |
Vidarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013