Phase II Study of Rituximab (Rituxan, Mabthera) in 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (delay in disease progression or timing of disease progression)
Define objective response (delay in disease progression or timing of disease progression), time to treatment failure, and toxicity for single agent Rituxan therapy in Waldenstrom's macroglobulinemia patients
Christos E. Emmanouilides, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|