Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
NCT ID: NCT00274976
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2002-09-30
2009-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.
Detailed Description
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* Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.
* Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain \[IgVH\] status, del \[17p\], del \[11q\]) treated with subcutaneous alemtuzumab after progression on fludarabine.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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alemtuzumab
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)
* Fludarabine-refractory disease
* Requires treatment
PATIENT CHARACTERISTICS:
* Life expectancy more than 6 months
* ECOG 0-2
* No severe organ dysfunction
* No other concomitant or previous neoplasms
* No autoimmune hemolytic anemia or thrombocytopenia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Up to 5 prior chemotherapy regimens allowed
18 Years
65 Years
ALL
No
Sponsors
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German CLL Study Group
OTHER
Principal Investigators
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Stephan Stilgenbauer, MD
Role:
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Locations
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Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, , Germany
Specialist Practice for Oncology
Aschaffenburg, , Germany
Humaine - Clinic
Bad Saarow, , Germany
Haematolo-Onkologische Schwerpunktpraxis - Berlin
Berlin, , Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Hospital Kuchwald Chemnitz
Chemnitz, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, , Germany
Internistische Gemeinschaftspraxis - Halle
Halle, , Germany
Praxis fur Innere Medizin - Hamburg
Hamburg, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Evangelische Krankenhaus Hamm
Hamm, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
Marienhospital at Ruhr University Bochum
Herne, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, , Germany
Internistische Gemeinschaftspraxis - Kassel
Kassel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Internistische Praxis - Landshut
Landshut, , Germany
Klinikum Lippe - Lemgo
Lemgo, , Germany
III Medizinische Klinik Mannheim
Mannheim, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, , Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, , Germany
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Countries
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References
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Stilgenbauer S, Zenz T, Winkler D, Buhler A, Schlenk RF, Groner S, Busch R, Hensel M, Duhrsen U, Finke J, Dreger P, Jager U, Lengfelder E, Hohloch K, Soling U, Schlag R, Kneba M, Hallek M, Dohner H; German Chronic Lymphocytic Leukemia Study Group. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009 Aug 20;27(24):3994-4001. doi: 10.1200/JCO.2008.21.1128. Epub 2009 Jul 13.
Zenz T, Habe S, Denzel T, Mohr J, Winkler D, Buhler A, Sarno A, Groner S, Mertens D, Busch R, Hallek M, Dohner H, Stilgenbauer S. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009 Sep 24;114(13):2589-97. doi: 10.1182/blood-2009-05-224071. Epub 2009 Jul 30.
Stilgenbauer S, Zenz T, Winkler D, et al.: Subcutaneous alemtuzumab (Campath) in fludarabine-refractory CLL: final results of the CLL2H trial of the GCLLSG and comprehensive analysis of prognostic markers. [Abstract] Blood 112 (11): A-329, 2008.
Schnaiter A, Paschka P, Rossi M, Zenz T, Buhler A, Winkler D, Cazzola M, Dohner K, Edelmann J, Mertens D, Kless S, Mack S, Busch R, Hallek M, Dohner H, Stilgenbauer S. NOTCH1, SF3B1, and TP53 mutations in fludarabine-refractory CLL patients treated with alemtuzumab: results from the CLL2H trial of the GCLLSG. Blood. 2013 Aug 15;122(7):1266-70. doi: 10.1182/blood-2013-03-488197. Epub 2013 Jul 2.
Other Identifiers
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GCLLSG-CLL2H
Identifier Type: -
Identifier Source: secondary_id
EU-20550
Identifier Type: -
Identifier Source: secondary_id
MEDAC-GCLLSG-CLL2H
Identifier Type: -
Identifier Source: secondary_id
AMGEN-GCLLSG-CLL2H
Identifier Type: -
Identifier Source: secondary_id
CDR0000455059
Identifier Type: -
Identifier Source: org_study_id