Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Arizona Oncology Associates; Bayer; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital; Northwestern University; University of California, Los Angeles
• Treatments: Alemtuzumab; Antibodies

Criteria

Inclusion Criteria:

• Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia

• Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.

• Age greater than 18 years

• Life expectancy of 6 months or greater

• ECOG performance status of 0-2

Exclusion Criteria:

• Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.

• Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.

• Pregnant women

• Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.