Method of Treating Mixed Lineage Leukemia Gene-Rearranged Acute Lymphoblastic Leukemias

Abstract

The present invention relates to a method of treating a warm-blooded animal, especially a human, having Mixed Lineage Leukemia (MLL rearranged ALL) comprising administering to said animal a therapeutically effective amount of a staurosporine derivative, especially PKC412 or a pharmaceutically acceptable salt thereof, alone or in combination with further therapeutic measures, for example, those defined herein; to the use of a staurosporine derivative for the preparation of a medicament for the treatment of MLL rearranged ALL; and to a commercial package comprising a staurosporine derivative together with instructions for its use in the treatment of MLL rearranged ALL.

1 . A method of treating mixed lineage leukemia gene rearranged acute lymphoblastic leukemia (MLL rearranged ALL) comprising administering a therapeutically effective amount of a staurosporine derivative to a warm-blooded animal having MLL rearranged ALL. 
     
     
         2 . The method according to  claim 1  comprising administering a therapeutically effective amount of PKC412 or a pharmaceutically acceptable salt thereof. 
     
     
         3 . The method according to  claim 1  wherein the warm-blooded animal is a human. 
     
     
         4 . The method according to  claim 3  which comprises administering PKC412, or a pharmaceutically acceptable salt thereof, to the patient on a once daily schedule at a dose in the range from 100 mg/day to 1000 mg/day. 
     
     
         5 . The method according to  claim 4  wherein the once daily dose is in the range from 150 mg/day to 500 mg/day. 
     
     
         6 . The method according to  claim 5  wherein the once daily dose is 225 mg/day. 
     
     
         7 . A method of treating MLL rearranged ALL comprising administering a staurosporine derivative in an amount which is therapeutically effective against MLL rearranged ALL to a warm-blooded animal in need thereof in combination with radiation therapy, in particular external radiation therapy or internal radiation therapy, or administration of other therapeutic agents. 
     
     
         8 . A commercial package comprising a staurosporine derivative together with instructions for use thereof in the treatment of MLL rearranged ALL. 
     
     
         9 . Use of a staurosporine derivative for the manufacture of a medicament for the treatment of MLL rearranged ALL. 
     
     
         10 . The use according to  claim 9  wherein the staurosporine derivative is PKC412 or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The method according to  claim 2  wherein the warm-blooded animal is a human. 
     
     
         12 . The method according to  claim 11  which comprises administering PKC412, or a pharmaceutically acceptable salt thereof, to the patient on a once daily schedule at a dose in the range from 100 mg/day to 1000 mg/day. 
     
     
         13 . The method according to  claim 12  wherein the once daily dose is in the range from 150 mg/day to 500 mg/day. 
     
     
         14 . The method according to  claim 14  wherein the once daily dose is 225 mg/day.