Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.

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

Details

• Lead Sponsor: Steven P. Treon, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Cape Cod Healthcare; Cape Cod Hospital; Dana-Farber Cancer Institute; Massachusetts General Hospital
• Treatments: Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy

• Baseline staging requirements

• Absolute Neutrophil Count > 500/microliter (uL)

• Platelet Count > 25,000/uL

• Serum creatinine < 2.5mg/dL

• Total bilirubin and transaminase (SGOT) < 2.5 X Upper Limit of Normal (ULN)

• Greater than 18 years of age

• Life expectancy of 3 months or greater

• Eastern Cooperative Oncology Group (ECOG) status performance of 0-2

Exclusion Criteria:

• Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry

• Pregnant or lactating women

• Serious co-morbid disease

• Uncontrolled bacterial, fungal or viral infection

• Active second malignancy