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| ID | Type | Description | Link |
|---|---|---|---|
| GCLLSG-CLL2H | |||
| EU-20550 | |||
| MEDAC-GCLLSG-CLL2H | |||
| AMGEN-GCLLSG-CLL2H |
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RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy | ||
| Response |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Stilgenbauer, MD | Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus der Stadt Wien | Vienna | A-1090 | Austria | |||
| Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19597025 | Result | 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. | |
| 19643983 |
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| Ansbach |
| 91522 |
| Germany |
| Specialist Practice for Oncology | Aschaffenburg | 63739 | Germany |
| Humaine - Clinic | Bad Saarow | 15526 | Germany |
| Haematolo-Onkologische Schwerpunktpraxis - Berlin | Berlin | 13357 | Germany |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | Berlin | D-13122 | Germany |
| Hospital Kuchwald Chemnitz | Chemnitz | 09113 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Staedtische Kliniken Esslingen | Esslingen am Neckar | 73730 | Germany |
| Krankenhaus Nordwest | Frankfurt | D-60488 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | D-79106 | Germany |
| Universitaetsklinikum Goettingen | Göttingen | D-37075 | Germany |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | Greifswald | D-17487 | Germany |
| St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH | Hagen | 58095 | Germany |
| Internistische Gemeinschaftspraxis - Halle | Halle | 06110 | Germany |
| Praxis fur Innere Medizin - Hamburg | Hamburg | 22457 | Germany |
| Asklepios Klinik St. Georg | Hamburg | D-20099 | Germany |
| Evangelische Krankenhaus Hamm | Hamm | DOH-59063 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Universitaets-Kinderklinik Heidelberg | Heidelberg | D-69120 | Germany |
| Marienhospital at Ruhr University Bochum | Herne | D-44625 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | D-66421 | Germany |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | Idar-Oberstein | D-55743 | Germany |
| Internistische Gemeinschaftspraxis - Kassel | Kassel | 34117 | Germany |
| University Hospital Schleswig-Holstein - Kiel Campus | Kiel | D-24105 | Germany |
| Internistische Praxis - Landshut | Landshut | 84028 | Germany |
| Klinikum Lippe - Lemgo | Lemgo | D-32657 | Germany |
| III Medizinische Klinik Mannheim | Mannheim | D-68305 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
| Klinikum Oldenburg | Oldenburg | D-26133 | Germany |
| St. Marien - Krankenhaus Siegen GMBH | Siegen | D-57072 | Germany |
| Southwest German Cancer Center at Eberhard-Karls-University | Tübingen | D-72076 | Germany |
| Universitaetsklinikum Ulm | Ulm | D-89081 | Germany |
| Hamatologisch - Onkologische Praxis Wurzburg | Würzburg | 97070 | Germany |
| Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg | Würzburg | D- | Germany |
| Result |
| 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. |
| Result | 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. |
| 23821658 | Derived | 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. |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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