The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration (FDA). It is used to treat some forms of cancer-like illnesses (myelodysplastic syndrome (MDS)and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood). This drug works by stimulating the body's immune system and by reducing the blood supply to cancer cells. Cancer cells need blood to live and grow. In this study, the drug is considered a new or experimental drug because we are learning how it works against your form of lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patient enrollment FNA of palpable lymph node prior to escalation phase Escalation phase of Lenalidomide: Lenalidomide 5 mg daily PO x 14 days Lenalidomide 10 mg daily PO x 14 days Lenalidomide 15 mg daily PO x 14 days Week of rest FNA of palpable lymph node prior to treatment phase Treatment phase of Lenalidomide: 15 mg daily PO days 1-21 out of a 28 day cycle Repeat x 6 cycles
Response rate (CR + PR).
The primary objective of this study is to evaluate lenalidomide in previously untreated patients with advanced stage follicular lymphoma who do not require active lymphoma therapy.
Time frame: 2 years
Response rate (CR + PR) and time to disease progression
according to FLIPI score. The Follicular Lymphoma International Prognostic Index (FLIPI)
Time frame: 2 years
Immune monitoring and analysis of signal transduction in the lymph node.
Time frame: 2 years
Immune monitoring and analysis of signal transduction in the blood.
Time frame: 2 years
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