Combination treatment of acute myeloid leukemia and myelodysplastic syndrome
The present invention relates to the use of Volasertib or a salt thereof or the hydrate thereof in combination with Quizartinib or a salt thereof or the hydrate thereof for treating patients suffering from acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
1. A method of treating a patient suffering from myeloid leukemia (AML) and/or myelodysplastic syndrome (MDS), comprising: administering to the patient Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof, wherein the Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof are administered simultaneously, separately or sequentially.
2. The method of claim 1 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof, are administered according to a dosage schedule (I), comprising:
a) administration of a therapeutically effective amount of Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof on minimally one day during a 4 week treatment cycle and
b) administration of a therapeutically effective amount of Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof on at least one day of the said 4 week treatment cycle,
to the patient.
3. The method of claim 1 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof are administered according to a dosage schedule (I), comprising:
a) administration of a therapeutically effective amount of Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof on minimally two days during a 4 week treatment cycle and
b) administration of a therapeutically effective amount of Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof on at least one day of the said 4 week treatment cycle,
to the patient.
4. The method of claim 1 , wherein 250 to 500 mg of Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered per day of administration.
5. The method of claim 1 , wherein 40 to 200 mg of Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered per day of administration.
6. The method of claim 1 , wherein Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on all days during the 4 week treatment cycle.
7. The method of claim 2 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 2-14 and 16-28 during the 4 week treatment cycle.
8. The method of claim 2 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 3-13 and 17-27 during the 4 week treatment cycle.
9. The method of claim 2 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 16-28 during the 4 week treatment cycle.
10. The method of claim 3 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 2-14 and 16-28 during the 4 week treatment cycle.
11. The method of claim 3 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 3-13 and 17-27 during the 4 week treatment cycle.
12. The method of claim 3 , wherein Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on day 1 and 15, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof is administered on days 16-28 during the 4 week treatment cycle.
13. A pharmaceutical composition comprising an effective amount of Volasertib or a pharmaceutically acceptable salt thereof or a hydrate thereof, and an effective amount of Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof.
14. The pharmaceutical composition according to claim 13 for treating AML and/or MDS.
15. A pharmaceutical combination comprising Volasertibor a pharmaceutically acceptable salt thereof or a hydrate thereof, and Quizartinib or a pharmaceutically acceptable salt thereof or a hydrate thereof, for simultaneous, separate or sequential administration to and treatment of a patient suffering from AML and/or MDS.