Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

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. Identifier: NCT00081068
Recruitment Status : Withdrawn
First Posted : April 8, 2004
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

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

Detailed Description:


  • Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
  • Determine the time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study Start Date : January 2004

Primary Outcome Measures :
  1. Objective response
  2. Time to treatment failure
  3. Toxicity

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

    • Immunoglobulin (Ig) M, IgG, and IgA paraprotein
    • Measurable monoclonal paraprotein
  • Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
  • CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


  • Absolute neutrophil count ≥ 500/mm^3
  • Platelet count ≥ 25,000/mm^3


  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN


  • Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 6 months after study participation
  • No serious comorbid disease
  • No uncontrolled bacterial, fungal, or viral infection
  • No other active malignancy


Biologic therapy

  • See Disease Characteristics
  • No prior alemtuzumab
  • More than 3 months since other prior monoclonal antibody therapy


  • See Disease Characteristics
  • More than 21 days since prior chemotherapy

Endocrine therapy

  • More than 21 days since prior steroid therapy


  • More than 21 days since prior radiotherapy


  • Not specified

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 identifier (NCT number): NCT00081068

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
United States, Colorado
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States, 80218
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, ON L8N 3Z5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C1
Centre Hospitalier Lens
Lens, France, 62307
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Jennifer Gansert, MD, PhD Jonsson Comprehensive Cancer Center Identifier: NCT00081068     History of Changes
Other Study ID Numbers: CDR0000358811
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents