Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine

NCT00274976 | Completed Phase 2

• 5 other identifiers: CDR0000455059GCLLSG-CLL2HEU-20550MEDAC-GCLLSG-CLL2HAMGEN-GCLLSG-CLL2H
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 35

Brief Summary

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.

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

• Safety and efficacy

• Response

Interventions

alemtuzumab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German CLL Study Group: lead

Study Sites (35)

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

Ansbach, 91522, Germany

Location

Specialist Practice for Oncology

Aschaffenburg, 63739, Germany

Location

Humaine - Clinic

Bad Saarow, 15526, Germany

Location

Haematolo-Onkologische Schwerpunktpraxis - Berlin

Berlin, 13357, Germany

Location

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, D-13122, Germany

Location

Hospital Kuchwald Chemnitz

Chemnitz, 09113, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Staedtische Kliniken Esslingen

Esslingen am Neckar, 73730, Germany

Location

Krankenhaus Nordwest

Frankfurt, D-60488, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, 58095, Germany

Location

Internistische Gemeinschaftspraxis - Halle

Halle, 06110, Germany

Location

Praxis fur Innere Medizin - Hamburg

Hamburg, 22457, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, DOH-59063, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

Marienhospital at Ruhr University Bochum

Herne, D-44625, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66421, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Internistische Gemeinschaftspraxis - Kassel

Kassel, 34117, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Internistische Praxis - Landshut

Landshut, 84028, Germany

Location

Klinikum Lippe - Lemgo

Lemgo, D-32657, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68305, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

St. Marien - Krankenhaus Siegen GMBH

Siegen, D-57072, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

Hamatologisch - Onkologische Praxis Wurzburg

Würzburg, 97070, Germany

Location

Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

Würzburg, D-, Germany

Location

Related Publications (4)

• 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.

  PMID: 19597025 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.

  PMID: 19643983 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.

  RESULT

• 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.

  PMID: 23821658 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stephan Stilgenbauer, MD

  Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: September 1, 2002
• Study Completion: August 1, 2009
• Last Updated: November 6, 2013

Record last verified: 2006-05

Locations

DE (34); AU (1)