Method for treating acute myeloid leukemia

Abstract

The present invention relates to the use of BI 6727 or a salt thereof or the hydrate thereof for treating patients suffering from acute myeloid leukemia (AML) comprising the administration of a high dose of BI 6727 according to a specific dosage schedule, optionally in combination with cytarabine.

1 . A method of treating acute myeloid leukemia (AML) comprising administering 350 to 500 mg of BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof to a patient suffering from AML. 
     
     
         2 . The method according to  claim 1  having a dosage schedule (I) comprising of
 a) administering an effective amount of BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof at least two days during a 4 week treatment cycle and 
 b) administering an effective amount of Cytarabine at least at one day of the said 4 week treatment cycle 
 to a patient suffering from AML. 
 
     
     
         3 . The method according to  claim 2 , wherein BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered at day 1 and at one of the days 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 during a 4 week treatment cycle. 
     
     
         4 . The method according to  claim 2 , wherein 350 to 500 mg of BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof are administered per day of administration. 
     
     
         5 . The method according to  claim 2 , wherein Cytarabine is administered at 10 days of the said 4 week treatment cycle. 
     
     
         6 . The method according to  claim 2 , wherein Cytarabine is administered from day 1 to 10 of the said 4 week treatment cycle. 
     
     
         7 . The method according to  claim 2 , wherein 40 mg Cytarabine are administered per day of administration. 
     
     
         8 . The method according to  claim 1  wherein the AML is relapsed AML. 
     
     
         9 . The method according to  claim 1  wherein the AML is refractory AML. 
     
     
         10 . The method according to  claim 1  wherein the patient suffering from AML is ineligible for intensive treatment. 
     
     
         11 . The method according to  claim 2 , wherein BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered at 350 mg/application. 
     
     
         12 . A pharmaceutical kit, comprising a first compartment which comprises an effective amount of BI 6727 or a pharmaceutically acceptable salt thereof or a hydrate thereof and a second compartment which comprises an effective amount of Cytarabine, optionally together with an instruction for administration of both active ingredients to a patient suffering from AML, wherein according to said instruction BI 6727 in a dosage of 350, 400, 450 or 500 mg and Cytarabine in a dosage of 40 mg/day is to be administered according to dosage schedule of  claim 2 .