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Details for Patent: 8,404,716

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Details for Patent: 8,404,716

Title:Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine
Abstract: Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administrations of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione in combination with 5-azacytidine.
Inventor(s): Zeldis; Jerome B. (Princeton, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Filing Date:May 11, 2010
Application Number:12/777,765
Claims:1. A method of treating a myelodysplastic syndrome, which comprises (a) administering to a patient in need thereof a therapeutically effective amount of 5-azacytidine for a period of time followed by a period of rest; (b) repeating step (a); (c) administering to the patient from about 5 mg per day to about 25 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione or a pharmaceutically acceptable salt thereof for a period of time followed by a period of rest; and (d) repeating step (c).

2. The method of claim 1, wherein the myelodysplastic syndrome is refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic leukemia.

3. The method of claim 1, wherein the myelodysplastic syndrome is Intermediate-2 or High risk in international prognostic scoring system (IPSS).

4. The method of claim 1, which further comprises administering to the patient a therapeutically effective amount of at least one additional active agent.

5. The method of claim 4, wherein the additional active agent is capable of improving blood cell production.

6. The method of claim 4, wherein the additional active agent is a cytokine, hematopoietic growth factor, anti-cancer agent, antibiotic, proteasome inhibitor, or immunosuppressive agent.

7. The method of claim 4, wherein the additional active agent is gemtuzumab ozogamicin, etanercept, imatinib, anti-TNF-.alpha. antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan, pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL18, Ara-C, vinorelbine, isotretinoin, 13-cis-retinoic acid, or a pharmacologically active mutant or derivative thereof.

8. The method of claim 1, wherein the patient has a Del5q31-33 abnormality.

9. The method of claim 1, wherein the myelodysplastic syndrome is primary or secondary.

10. The method of claim 1, wherein the 5-azacytidine is administered subcutaneously, intravenously, or orally.

11. The method of claim 1, wherein the 3-(4-amino-1-oxo-1,3 dihydro-isoindol 2 yl)-piperidine-2,6-dione is administered orally.

12. The method of claim 1, wherein 5-azacytidine is subcutaneously administered in an amount of about 25 mg/m.sup.2/day to about 75 mg/m.sup.2/day for days 1-7 every 28 days.

13. The method of claim 1, wherein 5-azacytidine is subcutaneously administered in an amount of about 25 mg/m.sup.2/day to about 75 mg/m.sup.2/day for days 1-5 every 28 days.

14. The method of claim 1, wherein 5-azacytidine is orally administered in an amount of 120 mg per day for days 1-7 every 28 days.

15. The method of claim 12, 13 or 14, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally in an amount of about 5 mg to about 25 mg per day for twenty-one days followed by seven days rest every 28 days.

16. The method of claim 1, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol 2-yl)-piperidine-2,6-dione is administered cyclically in an amount of about 5 mg to about 25 mg per day for fourteen days followed by fourteen days rest every 28 days.

17. The method of claim 1, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally in an amount of about 10 mg per day for twenty-one days followed by seven days rest every 28 days.

18. A method of improving survival of a patient having higher risk myelodysplastic syndrome, which comprises (a) administering to a patient having a higher risk myelodysplastic syndrome a therapeutically effective amount of 5-azacytidine for a period of time followed by a period of rest; (b) repeating step (a); (c) administering to the patient from about 5 mg per day to about 25 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione or a pharmaceutically acceptable salt thereof for a period of time followed by a period of rest; and (d) repeating step (c).

19. The method of claim 18, wherein a higher risk myelodysplastic syndrome is Intermediate-2 or High risk in international prognostic scoring system (IPSS), or refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic leukemia having 10-29% marrow blasts.

20. The method of claim 18, wherein the 5-azacytidine is administered subcutaneously, intravenously, or orally.

21. The method of claim 18, wherein the 3-(4-amino-1-oxo-1,3-dihydro isoindol-2-yl)-piperidine-2,6-dione is administered orally.

22. The method of claim 18, wherein 5-azacytidine is subcutaneously administered in an amount of about 25 mg/m.sup.2/day to about 75 mg/m.sup.2/day for days 1-7 every 28 days.

23. The method of claim 18, wherein 5-azacytidine is subcutaneously administered in an amount of about 25 mg/m.sup.2/day to about 75 mg/m.sup.2/day for days 1-5 every 28 days.

24. The method of claim 18, wherein 5-azacytidine is orally administered in an amount of 120 mg per day for days 1-7 every 28 days.

25. The method of claim 22, 23 or 24, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally in an amount of about 5 mg to about 25 mg per day for twenty-one days followed by seven days rest every 28 days.

26. The method of claim 18, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol 2-yl)-piperidine-2,6-dione is administered cyclically in an amount of about 5 mg to about 25 mg per day for fourteen days followed by fourteen days rest every 28 days.

27. The method of claim 18, wherein the 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally in an amount of about 10 mg per day for twenty-one days followed by seven days rest every 28 days.

28. The method of claim 18, which further comprises administering to the patient a therapeutically effective amount of at least one additional active agent.

29. The method of claim 28, wherein the additional active agent is gemtuzumab ozogamicin, etanercept, imatinib, anti-TNF-.alpha. antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan, pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL18, Ara-C, vinorelbine, isotretinoin, 13-cis-retinoic acid, or a pharmacologically active mutant or derivative thereof, or a combination thereof.

30. The method of claim 4 or 28, wherein the additional active agent is gemtuzumab ozogamicin.

31. The method of claim 4 or 28, wherein the additional active agent is etanercept.

32. The method of claim 28, wherein the additional active agent is capable of improving blood cell production.

33. The method of claim 28, wherein the additional active agent is a cytokine, hematopoietic growth factor, anti-cancer agent, antibiotic, proteasome inhibitor, or immunosuppressive agent.

34. The method of claim 1 or 18, wherein 5-azacytidine is subcutaneously administered in an amount of about 75 mg/m.sup.2/day for days 1-5 every 28 days.

35. The method of claim 1 or 18, wherein 5-azacytidine is subcutaneously administered in an amount of about 50 mg/m.sup.2/day for days 1-5 and 8-12 every 28 days.

36. The method of claim 1 or 18, wherein 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione is orally administered in an amount of about 5 mg to about 10 mg per day for days 1-14 every 28 days.

37. The method of claim 1 or 18, wherein 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione is orally administered in an amount of about 5 mg to about 10 mg per day for days 1-21 every 28 days.
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