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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274976
First received: January 10, 2006
Last updated: November 5, 2013
Last verified: May 2006
  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
Study Completion Date: August 2009
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 5, 2013
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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014