NCT00020800

Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.

Detailed description

OBJECTIVES: * Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine. * Determine the toxicity of this regimen in these patients. * Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27. Patients are followed at least every 2 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
DRUG	fludarabine phosphate

Timeline

• Start date: 2001-09-01
• Primary completion: 2003-04-01
• First posted: 2003-01-27
• Last updated: 2013-01-08

Locations

18 sites across 4 countries: United States, Canada, Sweden, United Kingdom