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

Leukemia Clinical Trial

Official title:

Subcutaneous Campath-1H in Fludarabine-Refractory CLL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274976
• Other study ID #: CDR0000455059
• Secondary ID: GCLLSG-CLL2HEU-2
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: November 5, 2013
• Start date: September 2002
• Est. completion date: August 2009

Study information

• Verified date: May 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• alemtuzumab

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien	Vienna
Germany	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
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Universitaetsklinikum Goettingen	Goettingen
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	Asklepios Klinik St. Georg	Hamburg
Germany	Praxis fur Innere Medizin - Hamburg	Hamburg
Germany	Evangelische Krankenhaus Hamm	Hamm
Germany	Medizinische Hochschule Hannover	Hannover
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	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Germany	Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg	Wuerzburg
Germany	Hamatologisch - Onkologische Praxis Wurzburg	Wurzburg

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (3)

Stilgenbauer S, Zenz T, Winkler D, Bühler A, Schlenk RF, Groner S, Busch R, Hensel M, Dührsen U, Finke J, Dreger P, Jäger U, Lengfelder E, Hohloch K, Söling U, Schlag R, Kneba M, Hallek M, Döhner H; German Chronic Lymphocytic Leukemia Study Group. Subcuta — View 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.

Zenz T, Häbe S, Denzel T, Mohr J, Winkler D, Bühler A, Sarno A, Groner S, Mertens D, Busch R, Hallek M, Döhner H, Stilgenbauer S. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contrib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy			Yes
Primary	Response			No