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.|
|ClinicalTrials.gov Identifier: NCT00081068|
Recruitment Status : Withdrawn
First Posted : April 8, 2004
Last Update Posted : January 8, 2013
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|
- 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)|
|Official Title:||Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)|
|Study Start Date :||January 2004|
U.S. FDA Resources
- Objective response
- Time to treatment failure
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): 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|
|Peter MacCallum Cancer Centre|
|East Melbourne, Victoria, Australia, 3002|
|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|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Study Chair:||Jennifer Gansert, MD, PhD||Jonsson Comprehensive Cancer Center|