METHODS FOR TREATING LYMPHOMA

1 . A method of treating a T-cell lymphoma in a human patient in need thereof, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

2 . The method of claim 1 , wherein the T-cell lymphoma is relapsed or refractory T-cell lymphoma.

3 . The method of claim 1 , the T-cell lymphoma has not been previously treated with an agent for treating T-cell lymphoma.

4 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is selected from peripheral T-cell lymphomas, peripheral T-cell lymphomas not otherwise specified, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T-cell lymphoma, adult T-cell leukaemia/lymphoma, T-cell leukemia, nasal NK/T-cell lymphoma, hepatosplenic T-cell lymphoma, and cutaneous (skin) T-cell lymphoma.

5 . The method of claim 1 , wherein the T-cell lymphoma is relapsed or refractory peripheral T-cell lymphoma.

6 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is peripheral T-cell lymphoma not otherwise specified.

7 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is angioimmunoblastic lymphoma.

8 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is anaplastic large cell lymphoma.

9 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is hepatosplenic T-cell lymphoma.

10 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is enteropathy-associated T-cell lymphoma.

11 . The method of any one of claims 1-3 , wherein the T-cell lymphoma is cutaneous T-cell lymphoma.

12 . The method of claim 11 , wherein the cutaneous T-cell lymphoma is mycosis fungoides or Sézary syndrome.

13 . A method of treating a lymphoma in a human patient in need thereof and having one or more of mutations in FAT4, CCND3, MYOM2, ZMYM3, NOTCH1, KMT2D, TCF3, ARID1A, AXIN1, SYK, JAK1, JAK3, and/or TYK2, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

14 . A method of treating a lymphoma in a human patient in need thereof and having one or more of mutations in ZMYM3, KMT2D, FAT4, SYK, JAK1, JAK3, and/or TYK2,comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

15 . The method of claim 13 or 14 , wherein the patient further has one or more mutations in BCL2, and/or BCL 6 .

16 . The method of any one of claims 13-15 , wherein the lymphoma is relapsed or refractory lymphoma.

17 . The method of any one of claims 13-16 , wherein the lymphoma is indolent lymphoma or B cell acute lymphocytic leukemia.

18 . A method of treating lymphoma in a human patient in need thereof and having one or more of mutations in NOTCH1, SETD2, SIGLEC10, SPEN, PCLO, TET2, MK167, FAT3,KRAS, REL, HIST1H1E, KMT2C, KMT2D, and/or SF3B1, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

19 . A method of treating lymphoma in a human patient in need thereof and having one or more of mutations in SETD2, SIGLEC10, SPEN, PCLO, TET2, MK167, FAT3, KRAS, REL, HIST1H1E, KMT2C, KMT2D, and/or SF3B1, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

20. A method of treating lymphoma in a human patient in need thereof and having one or more of mutations in TET2, MK167, FAT3, KRAS, HIST1H1E, KMT2C, KMT2D, and/or SF3B1, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

21 . The method of any one of claims 18-20 , wherein the patient further has one or more mutations in SYK, JAK1, JAK2, JAK3, TYK2, TP53, STAT, A20 and/or ATM.

22 . A method of treating a follicular lymphoma or indolent non-Hodgkin's Lymphoma (iNHL) in a human patient in need thereof, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof to achieve and maintain a steady state minimum plasma cerdulatinib concentration of between about 0.05 μM to about 3 μM in the patient.

23 . A method of treating a chronic lymphocytic leukemia or small lymphocytic lymphoma in a human patient in need thereof, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof to achieve and maintain a steady state minimum plasma cerdulatinib concentration of between about 0.05 μM to about 3 μM in the patient.

24. A method of treating lymphoma in a human patient in need thereof wherein the lymphoma is progressive chronic lymphocytic leukemia, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

25. A method of treating lymphoma in a human patient in need thereof and expressing above normal baseline at least one protein from the group consisting of Mcl-1, GABA1, FoxP1, SOCS1, and SOCS3, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof.

26 . The method of any one of claims 1-25 , further comprising administering to the patient an effective amount of rituximab.

27 . A method of treating a lymphoma in a human patient in need thereof, comprising administering to the patient an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof and an effective amount of rituximab.

28 . The method of claim 27 , wherein the lymphoma is relapsed or refractory lymphoma.

29 . The method of any one of claims 27-28 , wherein the lymphoma is B-cell lymphoma.

30 . The method of any one of claims 27-29 , wherein the lymphoma is selected from the group consisting of non-Hodgkin's lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), transformed Follicular Lymphoma (tFL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL).

31 . The method of any one of claims 1-30 , wherein the effective amount of cerdulatinib is from about 10 mg to about 45 mg daily.

32 . The method of any one of claims 1-31 , wherein the effective amount of cerdulatinib is from about 15 mg to about 30 mg twice daily.

33 . The method of any one of claims 1-31 , wherein the effective amount of cerdulatinib is about 15 mg, 20 mg, 25 mg, or 30 mg twice daily.

34 . A composition comprising an effective amount of cerdulatinib or a pharmaceutically acceptable salt, co-crystal or solvate thereof and an effective amount of rituximab.

35 . The composition of claim 34 , wherein the effective amount of cerdulatinib is from about 10 mg to about 45 mg.

36 . The composition of claim 34 , wherein the effective amount of cerdulatinib is from about 15 mg to about 30 mg.