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RU-2026101903-A - Treatment of acute myeloid leukemia with olutasidenib, venetoclax, and a hypomethylating agent

RU2026101903ARU 2026101903 ARU2026101903 ARU 2026101903ARU-2026101903-A

Inventors

  • ЧАО Мве Мве
  • ДИНАРДО Кортни

Assignees

  • РИГЕЛ ФАРМАСЬЮТИКАЛЗ, ИНК.

Dates

Publication Date
20260508
Application Date
20240703
Priority Date
20230707

Claims (20)

  1. 1. A method for treating a patient with a hematological malignancy or precancerous condition, comprising administering an effective amount of olutasidenib in combination with venetoclax and a hypomethylating agent.
  2. 2. The method according to claim 1, characterized in that the hematological malignant neoplasm is acute myeloid leukemia (AML).
  3. 3. The method according to claim 1, characterized in that the hematological malignant neoplasm or precancerous condition is characterized by an IDH1 mutation.
  4. 4. The method according to any one of paragraphs 1-3, characterized in that the administration of the drug is repeated daily for 10 days or more.
  5. 5. The method according to any one of claims 1-4, characterized in that the amount of olutasidenib administered during the day is approximately 300 mg.
  6. 6. The method according to claim 5, characterized in that olutasidenib is administered at a dose of 150 mg twice a day.
  7. 7. The method according to any one of claims 1-6, characterized in that the amount of venetoclax administered during the day is from about 200 mg to about 800 mg.
  8. 8. The method according to claim 7, characterized in that the amount of venoclax administered during the day is approximately 200 mg.
  9. 9. The method according to claim 7, characterized in that the amount of venoclax administered during the day is approximately 400 mg.
  10. 10. The method according to claim 7, characterized in that the amount of venoclax administered during the day is approximately 600 mg.
  11. 11. The method according to claim 7, characterized in that the amount of venoclax administered during the day is approximately 800 mg.
  12. 12. The method according to any one of paragraphs 7-11, characterized in that venetoclax is administered once a day.
  13. 13. The method according to any one of paragraphs 1-12, characterized in that the hypomethylating agent comprises azacitidine.
  14. 14. The method according to claim 13, characterized in that azacitidine is administered daily at a dose of approximately 75 mg/ m2 .
  15. 15. The method according to claim 14, characterized in that azacitidine is administered once a day.
  16. 16. The method according to any one of paragraphs 1-12, characterized in that the hypomethylating agent comprises decitabine.
  17. 17. The method according to claim 16, characterized in that the daily dose of decitabine is approximately 35 mg.
  18. 18. The method according to claim 17, characterized in that decitabine is administered once a day.
  19. 19. The method according to any one of paragraphs 16-18, characterized in that the hypomethylating agent comprises cedazuridine.
  20. 20. The method according to claim 19, characterized in that cedazuridine is administered at a dose of 100 mg once a day.