Status:
COMPLETED
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Steven P. Treon, MD, PhD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Waldenstrom's Macroglobulinemia
Lymphoplasmacytic Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 resul...
Detailed Description
* Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will rem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00142116
Start Date
May 1 2003
End Date
February 1 2008
Last Update
June 2 2014
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215