Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
German CLL Study Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274976
First received: January 10, 2006
Last updated: October 31, 2009
Last verified: May 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: alemtuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Subcutaneous Campath-1H in Fludarabine-Refractory CLL |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Safety and efficacy [ Designated as safety issue: Yes ]
- Response [ Designated as safety issue: No ]
| Study Start Date: | September 2002 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274976
Locations
| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Germany | |
| Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie | |
| Ansbach, Germany, 91522 | |
| Specialist Practice for Oncology | |
| Aschaffenburg, Germany, 63739 | |
| Humaine - Clinic | |
| Bad Saarow, Germany, 15526 | |
| Haematolo-Onkologische Schwerpunktpraxis - Berlin | |
| Berlin, Germany, 13357 | |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | |
| Berlin, Germany, D-13122 | |
| Hospital Kuchwald Chemnitz | |
| Chemnitz, Germany, 09113 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Staedtische Kliniken Esslingen | |
| Esslingen, Germany, 73730 | |
| Krankenhaus Nordwest | |
| Frankfurt, Germany, D-60488 | |
| Universitaetsklinikum Freiburg | |
| Freiburg, Germany, D-79106 | |
| Universitaetsklinikum Goettingen | |
| Goettingen, Germany, D-37075 | |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | |
| Greifswald, Germany, D-17487 | |
| St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH | |
| Hagen, Germany, 58095 | |
| Internistische Gemeinschaftspraxis - Halle | |
| Halle, Germany, 06110 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, D-20099 | |
| Praxis fur Innere Medizin - Hamburg | |
| Hamburg, Germany, 22457 | |
| Evangelische Krankenhaus Hamm | |
| Hamm, Germany, DOH-59063 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Universitaets-Kinderklinik Heidelberg | |
| Heidelberg, Germany, D-69120 | |
| Marienhospital at Ruhr University Bochum | |
| Herne, Germany, D-44625 | |
| Universitaetsklinikum des Saarlandes | |
| Homburg, Germany, D-66421 | |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | |
| Idar-Oberstein, Germany, D-55743 | |
| Internistische Gemeinschaftspraxis - Kassel | |
| Kassel, Germany, 34117 | |
| University Hospital Schleswig-Holstein - Kiel Campus | |
| Kiel, Germany, D-24105 | |
| Internistische Praxis - Landshut | |
| Landshut, Germany, 84028 | |
| Klinikum Lippe - Lemgo | |
| Lemgo, Germany, D-32657 | |
| III Medizinische Klinik Mannheim | |
| Mannheim, Germany, D-68305 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Klinikum Oldenburg | |
| Oldenburg, Germany, D-26133 | |
| St. Marien - Krankenhaus Siegen GMBH | |
| Siegen, Germany, D-57072 | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| Universitaetsklinikum Ulm | |
| Ulm, Germany, D-89081 | |
| Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg | |
| Wuerzburg, Germany, D- | |
| Hamatologisch - Onkologische Praxis Wurzburg | |
| Wurzburg, Germany, 97070 | |
Sponsors and Collaborators
German CLL Study Group
Investigators
| Investigator: | Stephan Stilgenbauer, MD | Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00274976 History of Changes |
| Other Study ID Numbers: | CDR0000455059, GCLLSG-CLL2H, EU-20550, MEDAC-GCLLSG-CLL2H, AMGEN-GCLLSG-CLL2H |
| Study First Received: | January 10, 2006 |
| Last Updated: | October 31, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Fludarabine Alemtuzumab Campath 1G Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013