Clinical trial NCT00274976: Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
Official title: Subcutaneous Campath-1H in Fludarabine-Refractory CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: refractory chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and efficacy
measure: Response
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Ansbach
country: Germany
facility: Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
city: Aschaffenburg
country: Germany
facility: Specialist Practice for Oncology
city: Bad Saarow
country: Germany
facility: Humaine - Clinic
city: Berlin
country: Germany
facility: Haematolo-Onkologische Schwerpunktpraxis - Berlin
city: Berlin
country: Germany
facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
city: Chemnitz
country: Germany
facility: Hospital Kuchwald Chemnitz
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Esslingen
country: Germany
facility: Staedtische Kliniken Esslingen
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen
city: Greifswald
country: Germany
facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
city: Hagen
country: Germany
facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
city: Halle
country: Germany
facility: Internistische Gemeinschaftspraxis - Halle
city: Hamburg
country: Germany
facility: Praxis fur Innere Medizin - Hamburg
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamm
country: Germany
facility: Evangelische Krankenhaus Hamm
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitaets-Kinderklinik Heidelberg
city: Herne
country: Germany
facility: Marienhospital at Ruhr University Bochum
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Idar-Oberstein
country: Germany
facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology
city: Kassel
country: Germany
facility: Internistische Gemeinschaftspraxis - Kassel
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Landshut
country: Germany
facility: Internistische Praxis - Landshut
city: Lemgo
country: Germany
facility: Klinikum Lippe - Lemgo
city: Mannheim
country: Germany
facility: III Medizinische Klinik Mannheim
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Siegen
country: Germany
facility: St. Marien - Krankenhaus Siegen GMBH
city: Tuebingen
country: Germany
facility: Southwest German Cancer Center at Eberhard-Karls-University
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wuerzburg
country: Germany
facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
city: Wurzburg
country: Germany
facility: Hamatologisch - Onkologische Praxis Wurzburg
Study officials:
affiliation: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
name: Stephan Stilgenbauer, MD
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.