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1. WO2020112966 - PROCÉDÉS ET COMPOSITIONS THÉRAPEUTIQUES POUR TRAITER LA LEUCÉMIE MYÉLOÏDE AIGUË EN UTILISANT DU DEVIMISTAT

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Claims:

1. A method for treating acute myeloid leukemia in a patient in need thereof, comprising the step of administering to the patient:

a. devimistat,

b. cytarabine, and

c. mitoxantrone;

pursuant to an induction cycle of 14 days, wherein during the induction cycle the devimistat is administered as a single daily dose of about 2,000 mg/m2 on each of days 1, 2, 3, 4, and 5, the cytarabine is administered in five doses of about 1.0 g/m2 each every 12 hours beginning on day 3, and the mitoxantrone is administered as a single daily dose of about 6 mg/m2 on each of days 3, 4, and 5, in order to treat the acute myeloid leukemia.

2. A method for treating relapsed or refractory acute myeloid leukemia in a patient who is at least 50 years old, comprising the step of administering to a patient with relapsed or refractory acute myeloid leukemia who is at least 50 years old:

a. devimistat,

b. cytarabine, and

c. mitoxantrone;

pursuant to an induction cycle of 14 days, wherein during the induction cycle the devimistat is administered as a single daily dose of about 2,000 mg/m2 on each of days 1, 2, 3, 4, and 5, the cytarabine is administered in five doses of about 1.0 g/m2 each every 12 hours beginning on day 3, and the mitoxantrone is administered as a single daily dose of about 6 mg/m2 on each of days 3, 4, and 5, in order to treat the relapsed or refractory acute myeloid leukemia.

3. A method for treating relapsed or refractory acute myeloid leukemia in a patient who is at least 50 years old, comprising the step of administering to a patient with relapsed or refractory acute myeloid leukemia who is at least 50 years old devimistat, cytarabine, and mitoxantrone pursuant to an induction cycle of 14 days, wherein during the induction cycle a) the devimistat is administered as a single daily dose of about 2,000 mg/m2 on each of days 1, 2, 3, 4, and 5, wherein each devimistat dose being administered over 2 hours as a central line IV infusion, b) the cytarabine is administered in five doses of about 1.0 g/m2 each every 12 hours beginning on day 3 after completion of the devimistat infusion, wherein each cytarabine dose is administered over 3 hours as a central line IV infusion, and c) the mitoxantrone is administered as a single daily dose of about 6 mg/m2 on each of days 3, 4, and 5 after completion of the cytarabine infusion, wherein each mitoxantrone dose is administered over 15 minutes as a central line IV infusion.

4. The method of any of claims 1-3, further comprising the step of repeating the induction cycle.

5. The method of any of claims 1-3, further comprising the step of subsequently administering to the patient:

a. devimistat,

b. cytarabine, and

c. mitoxantrone;

pursuant to an abbreviated induction cycle of 14 days, wherein during the abbreviated induction cycle the devimistat is administered as a single daily dose of about 2,000 mg/m2 on each of days 1, 2, and 3, the cytarabine is administered in three doses of about 1.0 g/m2 each every 12 hours beginning on day 2, and the mitoxantrone is administered as a single daily dose of about 6 mg/m2 on each of days 2 and 3.

6. The method of any one of claims 1-5, further comprising the step of subsequently

administering to the patient:

a. devimistat,

b. cytarabine, and

c. mitoxantrone;

pursuant to consolidation cycle of 14 days, wherein during the consolidation cycle the devimistat is administered as a single daily dose of about 2,000 mg/m2 on each of days 1, 2, and 3, the cytarabine is administered in three doses of about 1.0 g/m2 each every 12 hours beginning on day 2, and the mitoxantrone is administered as a single daily dose of about 6 mg/m2 on each of days 2 and 3.

7. The method of claim 6, further comprising the step of repeating the consolidation cycle.

8. The method of any one of claims 1-6, further comprising the step of subsequently

administering to the patient devimistat pursuant to maintenance cycle of 28 days, wherein during the maintenance cycle the devimistat is administered as a single daily dose of about 2,500 mg/m2 on each of days 1, 2, 3, 4, and 5.

9. The method of claim 8, wherein the maintenance cycle is repeated at least once.

10. The method of any one of claims 1-9, wherein the patient is at least 60 years old.

11. The method of any one of claims 1-10, wherein the mitoxantrone is administered

intravenously to the patient as a solution prepared from its dihydrochloride salt.

12. The method of any one of claims 1-11, wherein the devimistat is administered

intravenously to the patient as a solution prepared by

a. providing a 50 mg/mL solution of devimistat in 1 M aqueous triethanolamine; and

b. diluting the 50 mg/mL solution with sterile 5% dextrose for injection (D5W) to a concentration as low as about 12.5 mg/mL.

13. The method of claim 12, wherein the 50 mg/mL solution is diluted with D5W to a

concentration of about 12.5 mg/mL.

14. The method of any one of claims 1-13, wherein the first, third, and fifth cytarabine doses are started less than or equal to 30 minutes after completion of the day 3, day 4, and day 5 devimistat infusions, and the mitoxantrone doses are started less than or equal to 30 minutes after completing the first, third, and fifth cytarabine infusions.

15. A medical kit, comprising (i) devimistat and (ii) instructions for treating acute myeloid leukemia in a patient according to the method of any preceding claim.