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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00274976
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Leukemia Biological: alemtuzumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Campath-1H in Fludarabine-Refractory CLL
Study Start Date : September 2002
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Alemtuzumab




Primary Outcome Measures :
  1. Safety and efficacy
  2. Response


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274976


Locations
Show Show 35 study locations
Sponsors and Collaborators
German CLL Study Group
Investigators
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OverallOfficial: Stephan Stilgenbauer, MD Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00274976    
Other Study ID Numbers: CDR0000455059
GCLLSG-CLL2H
EU-20550
MEDAC-GCLLSG-CLL2H
AMGEN-GCLLSG-CLL2H
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: May 2006
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:
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Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents