Pharmaceutical composition for treatment or remission of chronic myelogenous leukemia

Abstract

The present application provides a pharmaceutical composition for use in treatment or remission of patients with chronic myelogenous leukemia, wherein the composition comprises, as active ingredients, (2S)-2-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutanoylamino]-4-methylpentanoic acid or a pharmacologically acceptable salt thereof, and 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide or a pharmacologically acceptable salt thereof, both of which are used at low doses.

1 . A pharmaceutical composition for use in the treatment or remission of a patient with chronic myelogenous leukemia, wherein the composition comprises, as active ingredients, (2 S)-2-[(2 S,3R)-3-amino-2-hydroxy-4-phenylbutanoylamino]-4-methylpentanoic acid or a pharmacologically acceptable salt thereof, and 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide or a pharmacologically acceptable salt thereof. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , characterized in that the composition is used to administer (2S)-2-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutanoylamino]-4-methylpentanoic acid or a pharmacologically acceptable salt thereof at a dose of 5 to 20 mg/day, and 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide or a pharmacologically acceptable salt thereof at a dose of 50 to 200 mg/day, respectively, to the patient one to three times a day. 
     
     
         3 . The pharmaceutical composition according to  claim 1  or  2 , characterized in that the composition is used to administer (2S)-2-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutanoylamino]-4-methylpentanoic acid or a pharmacologically acceptable salt thereof at a dose of 10 mg/day and 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide or a pharmacologically acceptable salt thereof at a dose of 100 mg/day, respectively, to the patient one to three times a day. 
     
     
         4 . The pharmaceutical composition according to  claim 2 , wherein the administering is oral administration. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the patient is in a range from neutral to alkaline with regard to pH value of the urine. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , which comprises the two active ingredients in the form of a compounding agent. 
     
     
         7 . The pharmaceutical composition according to  claim 1 , which comprises the two active ingredients in the form of a kit preparation.