NCT00081068

Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	alemtuzumab

Timeline

• Start date: 2004-01-01
• First posted: 2004-04-08
• Last updated: 2013-01-08

Locations

15 sites across 5 countries: United States, Australia, Canada, France, United Kingdom