Status:
TERMINATED
CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects ...
Detailed Description
* The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will re...
Eligibility Criteria
Inclusion
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
- Age 18 years or older
- CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
- Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.
- ECOG performance status of 0-2
- Absolute neutrophil count ≥ 100,000,000/L
- Platelet count ≥ 50,000,000,000/L
- Hemoglobin \> 8 g/dL
- Serum creatinine \< 2.5 mg/dL
- Total bilirubin \< 1.5 mg/dL
- AST and ALT \< 2.5 x ULN
- Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness
- Pregnant or lactating women
- Prior therapy with rituximab or CC-5103
- Known hypersensitivity to thalidomide
- Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00142168
Start Date
September 1 2004
End Date
April 1 2008
Last Update
April 21 2016
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215