Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders

1. A method of treating a condition characterized by elevated levels of B-cells in a subject, comprising:

administering to the subject in need thereof, a therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof,

wherein the condition is selected from the group consisting of diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma (MZL), small cell lymphocytic lymphoma, mantle cell lymphoma (MCL), Burkitt lymphoma, Waldenstrom's macroblobulinemia, B-cell leukemia, and any combination thereof.

2. The method of claim 1 , wherein the B-cell leukemia is selected from the group consisting of B-cell chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, B-cell acute lymphocytic leukemia, B-cell prolymphocytic leukemia, precursor B-cell lymphoblastic leukemia, hairy cell leukemia, and any combination thereof.

3. The method of claim 1 , wherein the condition is further characterized by elevated levels of B-cell prolymphocytes in the peripheral blood.

4. The method of claim 1 , wherein treating the condition results in a reduction of the levels of B-cells.

5. The method of claim 4 , wherein the reduction of the levels of B-cells is in peripheral blood, a tissue, or a combination thereof.

6. The method of claim 5 , wherein the tissue is selected from the group consisting of bone marrow, bone, kidney, lymph nodes, and any combinations thereof.

7. The method of claim 4 , wherein the levels of B-cells are reduced by about 10% to about 100%.

8. The method of claim 4 , wherein the levels of B-cells are reduced to normal.

9. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 1 mg to about 1,000 mg per day.

10. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 50 mg to about 600 mg per day.

11. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 150 mg to about 300 mg per day.

12. The method of claim 1 , wherein administering is selected from the group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering a dose equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours.

13. The method of claim 1 , wherein administering comprises administering about 150 mg two times per day.

14. The method of claim 1 , wherein administering comprises administering about 75 mg two times per day.

15. The method of claim 1 , wherein administering comprises administering about 300 mg two times per day.

16. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole, or a pharmaceutically acceptable salt thereof, is administered via a route of administration selected from the group consisting of orally, by inhalation, intranasally, via intravenous administration, topically, and any combination thereof.

17. The method of claim 1 , wherein the therapeutically effective amount is administered orally.

18. The method of claim 1 , further comprising an induction step, wherein said induction step is administering a therapeutic agent selected from the group consisting of a glucocorticoid, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a tyrosine kinase inhibitor, a fusion protein, a monoclonal antibody directed against one or more pro-inflammatory cytokines, a chemotherapeutic agent, a phenolic antioxidant, an anti-proliferative drug, an anti IL-5 monoclonal antibody, an IL-5 receptor monoclonal antibody, an anti IL-13 monoclonal antibody, an anti IL-13 receptor monoclonal antibody, an anti IL-4 monoclonal antibody, an anti IL-4 receptor monoclonal antibody, an anti IgE monoclonal antibody, a TNF-α inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof.

19. The method of claim 18 , wherein the tyrosine kinase inhibitor is imatinib.

20. The method of claim 18 , wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab, reslizumab, and combinations thereof.

21. The method of claim 18 , wherein the IL-5 receptor monoclonal antibody is benralizumab.

22. The method of claim 18 , wherein the anti IL-13 monoclonal antibody is lebrikizumab.

23. The method of claim 18 , wherein the anti IL-4 receptor monoclonal antibody is dupilumab.

24. The method of claim 18 , wherein the anti IgE monoclonal antibody is omalizumab.

25. The method of claim 18 , wherein the TNF-α inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, golimumab, and combinations thereof.

26. The method of claim 18 , wherein the fusion protein is etanercept.

27. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is administered as an initial dosing regimen and then as a maintenance dosing regimen.

28. The method of claim 27 , wherein the therapeutically effective amount of the initial dosing regimen is from about 50 mg to about 1,500 mg per day.

29. The method of claim 27 , wherein the therapeutically effective amount of the initial dosing regimen is from about 150 mg to about 300 mg per day.

30. The method of claim 27 , wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 500 mg per day.

31. The method of claim 27 , wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 600 mg per day.

32. The method of claim 27 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 50 mg to about 1,500 mg per day.

33. The method of claim 27 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 150 mg to about 300 mg per day.

34. The method of claim 27 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 500 mg per day.

35. The method of claim 27 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 600 mg per day.

36. The method of claim 18 , wherein said induction step is from about 1 week to about 6 months.