Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

• NCT number: NCT00081068
• Study type: Interventional
• Source: Jonsson Comprehensive Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2004