Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas

Abstract

Methods of treating, preventing or managing mantle cell lymphomas are disclosed. The methods encompass the administration of an immunomodulatory compound of the invention known as Revlimid® or lenalidomide. The invention further relates to methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods of the invention are also disclosed.

1 - 13 . (canceled) 
     
     
         14 . A method of treating mantle cell lymphoma, which comprises administering to a patient having mantle cell lymphoma from about 5 mg to about 50 mg of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione and a therapeutically effective amount of a second active agent selected from a hematopoietic growth factor, a cytokine, an anticancer agent, an antibiotic, a cox-2 inhibitor, a corticosteroid, rituximab, or a combination thereof. 
     
     
         15 . The method of  claim 14 , wherein the second active agent is rituximab. 
     
     
         16 . The method of  claim 14 , wherein the second active agent is dexamethasone. 
     
     
         17 . The method of  claim 14 , wherein the second active agent is prednisone. 
     
     
         18 . The method of  claim 14 , wherein the second active agent is a proteasome inhibitor. 
     
     
         19 . The method of  claim 14 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 5 mg to about 25 mg per day. 
     
     
         20 . The method of  claim 19 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 5 mg per day. 
     
     
         21 . The method of  claim 19 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 10 mg per day. 
     
     
         22 . The method of  claim 19 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 15 mg per day. 
     
     
         23 . The method of  claim 19 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 20 mg per day. 
     
     
         24 . The method of  claim 19 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 25 mg per day. 
     
     
         25 . The method of  claim 14 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally. 
     
     
         26 . The method of  claim 25 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered in the form of a capsule or tablet. 
     
     
         27 . The method of  claim 15 , wherein the rituximab is administered in an amount of 375 mg/m2 by intravenous infusion weekly.