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Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.
OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses. OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Start Date
December 1, 1999
Primary Completion Date
January 1, 2002
Completion Date
July 1, 2005
Last Updated
August 3, 2020
8
ACTUAL participants
rituximab
BIOLOGICAL
Lead Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
NCT06263491
NCT06337318
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05529069