Apilimod compositions and methods for using same

1. A method for treating a refractory or recurrent non-Hodgkin's B cell lymphoma in a humor subject in need thereof, the method comprising administering a pharmaceutical composition comprising apilimod dimesylate to the subject in a therapeutically effective amount of from 200-300 mg/day.

2. The method of claim 1 , wherein the pharmaceutical composition is an oral dosage form.

3. The method of claim 1 , wherein the non-Hodgkin's B cell lymphoma is selected from diffuse large B cell lymphoma (DLBCL), Burkitt's lymphoma, mediastinal B cell lymphoma, and mantle cell lymphoma.

4. The method of claim 3 , wherein the non-Hodgkins B cell lymphoma is DLBCL.

5. The method of claim 4 , wherein the DLBCL is DLBCL-GCB.

6. The method of claim 1 , wherein the method comprises administering apilimod in combination with at least one additional active agent.

7. The method of claim 6 , wherein the at least one additional active agent is a therapeutic agent or a non-therapeutic agent, or combinations thereof.

8. The method of claim 6 , wherein the at least one additional active agent is administered in the same dosage form as the apilimod, or in a separate dosage form.

9. The method of claim 7 , wherein the at least one additional active agent is selected from the group consisting of an alkylating agent, an intercalating agent, a tubulin binding agent, a corticosteroid, and combinations thereof.

10. The method of claim 7 , wherein the at least one additional active agent is a therapeutic agent selected from the group consisting of ibrutinib, rituximab, doxorubicin, prednisolone vincristine, velcade, and everolimus, and combinations thereof.

11. The method of claim 7 , wherein the at least one additional active agent is a therapeutic agent selected from cyclophosphamide, hydroxydaunorubicin (also referred to as doxorubicin or Adriamycin™), vincristine (also referred to as Oncovin™), prednisone, prednisolone, and combinations thereof.

12. The method of claim 7 , wherein the at least one additional active agent is a non-therapeutic agent selected to ameliorate one or more side effects of the apilimod composition.

13. The method of claim 12 , wherein the non-therapeutic agent is selected from the group consisting of ondansetron, granisetron, dolasetron and palonosetron.

14. The method of claim 12 , wherein the non-therapeutic agent is selected from the group consisting of pindolol and risperidone.

15. The method of claim 10 , wherein the therapeutic agent is rituximab.

16. The method of claim 10 , wherein the therapeutic agent is ibrutinib.

17. The method of claim 1 , wherein the non-Hodgkin's B cell lymphoma is a follicular lymphoma.

18. The method of claim 1 , wherein the amount is 200 mg/day, 225 mg/day, 250 mg/day, or 275 mg/day.