Dosage regimen for sapacitabine and decitabine in combination for treating acute myeloid leukemia

A method of treating acute myeloid leukemia (AML) in a subject of 70 years of age or over, said method comprising administering to the subject a therapeutically effective amount of (i) sapacitabine;

• and (ii) decitabine;
• in accordance with a dosing regimen comprising at least one first treatment cycle followed by at least one second treatment cycle,
• wherein said first treatment cycle comprises administering decitabine intravenously in a dose of about 20 mg/m2 per day for 5 consecutive days followed by a 3 to 5 week rest period, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering sapacitabine orally in a dose of about 300 mg b.i.d. for 3 consecutive days per week, for 2 weeks followed by a 2 to 4 week rest period, or until treatment-related toxicities are resolved, whichever is longer.

A method of treating acute myeloid leukemia (AML) in a subject of 75 years of age or over, said method comprising administering to the subject a therapeutically effective amount of (i) sapacitabine;

• and (ii) decitabine;
• in accordance with a dosing regimen comprising at least one first treatment cycle followed by at least one second treatment cycle,
• wherein said first treatment cycle comprises administering decitabine intravenously in a dose of about 20 mg/m2 per day for 5 consecutive days followed by a 3 to 5 week rest period, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering sapacitabine orally in a dose of about 300 mg b.i.d. for 3 consecutive days per week, for 2 weeks followed by a 2 to 4 week rest period, or until treatment-related toxicities are resolved, whichever is longer.

A method of treating acute myeloid leukemia (AML) in a subject of 75 years of age or over, said method comprising administering to the subject a therapeutically effective amount of (i) sapacitabine, or a metabolite thereof;

• and (ii) decitabine;
• in accordance with a dosing regimen comprising at least one first treatment cycle followed by at least one second treatment cycle,
• wherein said first treatment cycle comprises administering a therapeutically effective amount of decitabine for 5 consecutive days followed by a rest period of from 3 to 5 weeks, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering a therapeutically effective amount of sapacitabine, or a metabolite thereof, in a dose of about 100-400 mg b.i.d. for 3consecutive days per week, for 2 weeks followed by a rest period of from 2 to 4 weeks, or until treatment-related toxicities are resolved, whichever is longer.

A method of treating acute myeloid leukemia (AML) in a subject of 70 years of age or over, said method comprising administering to the subject a therapeutically effective amount of (i) sapacitabine, or a metabolite thereof;

• and (ii) decitabine;
• in accordance with a dosing regimen comprising at least one first treatment cycle followed by at least one second treatment cycle,
• wherein said first treatment cycle comprises administering a therapeutically effective amount of decitabine for 5 consecutive days followed by a rest period of from 3 to 5 weeks, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering a therapeutically effective amount of sapacitabine, or a metabolite thereof, in a dose of about 100-400 mg b.i.d. for 3consecutive days per week, for 2 weeks followed by a rest period of from 2 to 4 weeks, or until treatment-related toxicities are resolved, whichever is longer;
• and wherein said dosing regimen comprises two or more of each treatment cycle.