Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent
Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.
1. A method of treating non-Hodgkin's lymphoma, which comprises administering to a patient having non-Hodgkin's lymphoma about 1 to about 50 mg per day of a compound having the formula:
or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, and a therapeutically effective amount of a second active agent wherein the non-Hodgkin's lymphoma is follicular lymphoma and the second active agent is an anticancer agent.
2. The method of claim 1 , wherein the non-Hodgkin's lymphoma is relapsed, refractory, or relapsed and refractory.
3. The method of claim 1 , wherein the patient has received prior therapy for non-Hodgkin's lymphoma and has demonstrated progression on the prior therapy.
4. The method of claim 1 , wherein the patient has not received prior therapy for non-Hodgkin's lymphoma.
5. The method of claim 1 , wherein the non-Hodgkin's lymphoma is indolent lymphoma.
6. The method of claim 1 , wherein the non-Hodgkin's lymphoma is low grade follicular lymphoma.
7. The method of claim 1 , wherein the compound is
and is not a pharmaceutically acceptable salt or solvate.
8. The method of claim 1 , wherein the compound is a pharmaceutically acceptable salt or solvate.
9. The method of claim 1 , wherein the second active agent is rituximab, vinblastine, fludarabine, cyclophosphamide, vincristine, doxorubicin, prednisone, a proteasome inhibitor, dexamethasone, or a combination thereof.
10. The method of claim 9 , wherein the second active agent is rituximab.
11. The method of claim 9 , wherein the second active agent is dexamethasone.
12. The method of claim 1 , wherein the compound is administered for 21 consecutive days followed by 7 consecutive days of rest in a 28 day cycle.
13. The method of claim 1 , wherein the compound is administered every day.
14. The method of claim 1 , wherein the compound is administered until disease progression or unacceptable toxicity.
15. The method of claim 1 , wherein the compound is administered in an amount from about 1 to about 25 mg per day.
16. The method of claim 15 , wherein the compound is administered in an amount of about 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg per day.
17. The method of claim 16 , wherein the compound is administered in an amount of about 5 mg per day.
18. The method of claim 16 , wherein the compound is administered in an amount of about 10 mg per day.
19. The method of claim 16 , wherein the compound is administered in an amount of about 15 mg per day.
20. The method of claim 16 , wherein the compound is administered in an amount of about 20 mg per day.
21. The method of claim 16 , wherein the compound is administered in an amount of about 25 mg per day.
22. The method of claim 1 , wherein the compound is administered orally.
23. The method of claim 22 , wherein the compound is administered in the form of a capsule or tablet.
24. The method of claim 23 , wherein the compound is administered in a capsule in an amount from about 1 mg to about 50 mg.
25. The method of claim 24 , wherein the compound is administered in a capsule in an amount of about 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg.
26. The method of claim 24 , wherein the capsule comprises the compound, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
27. The method of claim 10 , wherein the rituximab is administered cyclically.
28. The method of claim 10 , wherein the rituximab is administered in an amount of about 375 mg/m 2 .