NCT00004889

Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.

Timeline

• Start date: 1999-12-01
• Primary completion: 2002-01-01
• Completion: 2005-07-01
• First posted: 2004-02-12
• Last updated: 2020-08-03

Locations

8 sites across 2 countries: United States, Canada