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

Abstract

Methods of treating, preventing or managing leukemias 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 . A method of treating leukemia in a human, which comprises administering to a human in need thereof a therapeutically effective amount of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione. 
     
     
         2 . The method of  claim 1 , wherein the leukemia is chronic lymphocytic leukemia, chronic myelocytic leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia or acute myeloblastic leukemia. 
     
     
         3 . The method of  claim 1 , wherein the leukemia is relapsed, refractory or resistant to conventional therapy. 
     
     
         4 . The method of  claim 1 , wherein the leukemia is chronic lymphocytic leukemia. 
     
     
         5 . The method of  claim 4 , wherein the leukemia is refractory or relapsed chronic lymphocytic leukemia. 
     
     
         6 . A method of treating leukemia, which comprises administering to a patient in need thereof a therapeutically effective amount 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. 
     
     
         7 . The method of  claim 6 , wherein the second active agent is antibody, hematopoietic growth factor, cytokine, anti-cancer agent, antibiotic, cox-2 inhibitor, immunomodulatory agent, immunosuppressive agent, corticosteroid, or a pharmacologically active mutant or derivative thereof. 
     
     
         8 . The method of  claim 6 , wherein the second active agent is rituximab. 
     
     
         9 . The method of  claim 8 , wherein the leukemia is chronic lymphocytic leukemia, chronic myelocytic leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia or acute myeloblastic leukemia. 
     
     
         10 . The method of  claim 8 , wherein the leukemia is chronic lymphocytic leukemia. 
     
     
         11 . The method of  claim 1 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is from about 1 to about 50 mg per day. 
     
     
         12 . The method of  claim 11 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 5, 10 or 25 mg per day. 
     
     
         13 . The method of  claim 1 , wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 1, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, or 50 mg per day. 
     
     
         14 . The method of  claim 1 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is enantiomerically pure. 
     
     
         15 . The method of  claim 14 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is S enantiomer. 
     
     
         16 . The method of  claim 14 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is R enantiomer. 
     
     
         17 . The method of  claim 1 , 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. 
     
     
         18 . The method of  claim 1 , wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered in an amount of about 25 mg per day for 21 days followed by seven days rest in a 28 day cycle. 
     
     
         19 . The method of  claim 18 , further comprising administration of rituximab in an amount of 375 mg/m 2 .