The goal of this clinical research study is to learn if a combination of ibrutinib, rituximab, and lenalidomide can help control newly diagnosed mantle cell lymphoma (MCL) in patients over 65. The safety of this drug combination will also be studied.
Name: Ibrutinib
Description: Orally at 560 mg daily for 28 days (one cycle) up to Cycle 11. Starting at Cycle 12, a 2 month supply of ibrutinib dispensed every other cycle. After 3 years, patients treated with ibrutinib in continuous cycles until progression of disease or unacceptable toxicity.Type: DrugIbrutinib + Rituximab + Lenalidomide
Name: Rituximab
Description: 375 mg/m^2 intravenous infusion (IV) given on Days 1, 8, 15 and 22 for Cycles 1 and 2. Then, Day 1 of every cycle, for Cycles 3 - 8. Following Cycle 8 Rituximab given on Day 1 of every other cycle for up to 2 years.Type: DrugIbrutinib + Rituximab + Lenalidomide
Name: Lenalidomide
Description: Orally at 20 mg daily on Days 1 - 21 of each 28 day cycle for up to one year.Type: DrugIbrutinib + Rituximab + Lenalidomide
Name: Dexamethasone Sodium Sulfate
Description: Orally 40 mg weekly administered only for the first 2 cycles.Type: DrugIbrutinib + Rituximab + Lenalidomide
Description: Response assessed according to the International Workshop Standardization Response Criteria for Non-Hodgkin's Lymphoma (Cheson, 2014)
Measure: Overall Response Rate (ORR) at 4 Months of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) Time: 4 monthsDescription: Adverse events assessed according to the Common Toxicity Criteria for Adverse Events version 4.03. (CTCAE v4.03)
Measure: Summary of Adverse Events of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) Time: After 1 cycle, 28 daysSingle Group Assignment
There is one SNP
Requires treatment with strong Cytochrome P4503A (CYP3A) inhibitors. --- P4503A ---