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

November 5, 2013 updated by: German CLL Study Group

Subcutaneous Campath-1H in Fludarabine-Refractory CLL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus der Stadt Wien
  • Germany
      • Ansbach, Germany, 91522
        • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
      • Aschaffenburg, Germany, 63739
        • Specialist Practice for Oncology
      • Bad Saarow, Germany, 15526
        • Humaine - Clinic
      • Berlin, Germany, D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Berlin, Germany, 13357
        • Haematolo-Onkologische Schwerpunktpraxis - Berlin
      • Chemnitz, Germany, 09113
        • Hospital Kuchwald Chemnitz
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Esslingen, Germany, 73730
        • Staedtische Kliniken Esslingen
      • Frankfurt, Germany, D-60488
        • Krankenhaus Nordwest
      • Freiburg, Germany, D-79106
        • Universitaetsklinikum Freiburg
      • Goettingen, Germany, D-37075
        • Universitaetsklinikum Goettingen
      • Greifswald, Germany, D-17487
        • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
      • Hagen, Germany, 58095
        • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
      • Halle, Germany, 06110
        • Internistische Gemeinschaftspraxis - Halle
      • Hamburg, Germany, D-20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 22457
        • Praxis fur Innere Medizin - Hamburg
      • Hamm, Germany, DOH-59063
        • Evangelische Krankenhaus Hamm
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, D-69120
        • Universitaets-Kinderklinik Heidelberg
      • Herne, Germany, D-44625
        • Marienhospital at Ruhr University Bochum
      • Homburg, Germany, D-66421
        • Universitaetsklinikum des Saarlandes
      • Idar-Oberstein, Germany, D-55743
        • Clinic for Bone Marrow Transplantation and Hematology and Oncology
      • Kassel, Germany, 34117
        • Internistische Gemeinschaftspraxis - Kassel
      • Kiel, Germany, D-24105
        • University Hospital Schleswig-Holstein - Kiel Campus
      • Landshut, Germany, 84028
        • Internistische Praxis - Landshut
      • Lemgo, Germany, D-32657
        • Klinikum Lippe - Lemgo
      • Mannheim, Germany, D-68305
        • III Medizinische Klinik Mannheim
      • Munich, Germany, D-81675
        • Klinikum Rechts der Isar - Technische Universitaet Muenchen
      • Oldenburg, Germany, D-26133
        • Klinikum Oldenburg
      • Siegen, Germany, D-57072
        • St. Marien - Krankenhaus Siegen GMBH
      • Tuebingen, Germany, D-72076
        • Southwest German Cancer Center at Eberhard-Karls-University
      • Ulm, Germany, D-89081
        • Universitaetsklinikum Ulm
      • Wuerzburg, Germany, D-
        • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
      • Wurzburg, Germany, 97070
        • Hamatologisch - Onkologische Praxis Wurzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy
Response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German CLL Study Group

Investigators

  • Stephan Stilgenbauer, MD, Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000455059
  • GCLLSG-CLL2H
  • EU-20550
  • MEDAC-GCLLSG-CLL2H
  • AMGEN-GCLLSG-CLL2H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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