Lenalidomide Therapy In Previously Untreated, Advanced Stage Follicular Lymphoma
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lenalidomide Therapy In Previously Untreated, Advanced Stage Follicular Lymphoma|
- Response rate (CR + PR). [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Response rate (CR + PR) and time to disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]according to FLIPI score. The Follicular Lymphoma International Prognostic Index (FLIPI)
- Immune monitoring and analysis of signal transduction in the lymph node. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Immune monitoring and analysis of signal transduction in the blood. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Eligible patients for this clinical trial will be treated for 6 cycles with lenalidomide at 15 mg daily by mouth on Days1-21 of 28 day cycle, preceded by an escalating schema for safety (5mg daily for 2 weeks; 10 mg daily for 2 weeks; and 15 mg daily for 2 weeks) and then a one week rest).
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