Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Completed · Phase 2

Conditions studied: Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma

In brief

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.

Key facts

Study ID

NCT00142116

Run by

Steven P. Treon, MD, PhD

People needed

25

Starts

2003-05-01

Expected to finish

2008-02-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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