Treatment of hematologic malignancies associated with circulating tumor cells using chimeric anti-CD20 antibody

• US 7,682,612 B1
• Filed: 11/09/1999
• Issued: 03/23/2010
• Est. Priority Date: 11/09/1998
• Status: Expired due to Fees

• Current Assignee: Biogen, Inc., Genentech, Inc. (Roche Holding AG)
• Original Assignee: Biogen Idec Inc (Biogen, Inc.), Genentech, Inc. (Roche Holding AG)
• Inventors: Desmond-Hellmann, Susan, White, Christine A., Curd, John G., Grillo-Lopez, Antonio J.
• Primary Examiner(s): DENT, ALANA HARRIS
• Application Number:
  US09/436,347
• Time in Patent Office: 3,787 Days
• Field of Search: 435/7.1, 435/7.2, 435/7.21, 435/7.23, 435/7.24, 435/7.25, 530/387.1, 530/387.3, 530/387.7, 530/388.1, 530/388.2, 530/388.73, 530/388.8, 530/388.85, 530/391.3, 530/350, 424/1.49, 424/133.1, 424/143.1, 424/144.1, 424/156.1, 424/174.1, 424/153.1, 424/138.1
• US Class Current: 424/138.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 31/7076 containing purines, e.g. adenosine, adenylic acid
• CPC Class Codes: A61K 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/2026 IL-4
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/2887 against CD20
• CPC Class Codes: C23C 2/06 Zinc or cadmium or alloys based thereon
• CPC Class Codes: C23C 2/30 Fluxes or coverings on molten baths C23C2/22 takes precedence

Abstract

Chronic Lymphocytic Leukemia (CLL) may be treated with antibodies directed against the CD20 antigen.

Claims

1. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

2. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.001 to about 30 mg/kg.

3. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.01 to about 25 mg/kg.

4. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.1 to about 20 mg/kg.

5. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 375 mg/m².

8. A method according to claim 1 or 6, wherein the patient has relapsed following previous treatment for the chronic lymphocytic leukemia.

9. A method according to claim 1 or 6, wherein the patient is refractory to a treatment previously administered for the chronic lymphocytic leukemia.

10. A method according to claim 9, wherein the patient is refractory to fludarabine.

11. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a chimeric antibody.

12. A method according to claim 11, wherein the anti-CD20 antibody is rituximab.

13. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a humanized antibody.

14. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a human antibody.

15. A method according to claim 1 or 6, wherein the anti-CD20 antibody comprises a CD20-binding fragment of a chimeric, humanized, or human antibody.

16. A method according to claim 1 or 6, wherein the anti-CD20 antibody is administered to the patient repeatedly.

17. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient weekly.

18. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient weekly for about 2 to 10 weeks.

19. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient biweekly.

20. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient monthly.

21. A method according to claim 1 or 6, wherein the anti-CD20 antibody is administered to the patient parenterally.

22. A method according to claim 21, wherein the anti-CD20 antibody is administered to the patient by intravenous infusion.

6. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 to about 1500 mg/m², wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

7. A method according to claim 6, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 mg/m².

23. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody therapy is combined with chemotherapy, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

24. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.001 to about 30 mg/kg.

25. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.01 to about 25 mg/kg.

26. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.1 to about 20 mg/kg.

27. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 375 mg/m².

30. A method according to claim 23 or 28, wherein the patient has relapsed following previous treatment for the chronic lymphocytic leukemia.

31. A method according to claim 23 or 28, wherein the patient is refractory to a treatment previously administered for the chronic lymphocytic leukemia.

32. A method according to claim 31, wherein the patient is refractory to fludarabine.

33. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a chimeric antibody.

34. A method according to claim 33, wherein the anti-CD20 antibody is rituximab.

35. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a humanized antibody.

36. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a human antibody.

37. A method according to claim 23 or 28, wherein the anti-CD20 antibody comprises a CD20-binding fragment of a chimeric, humanized, or human antibody.

38. A method according to claim 23 or 28, wherein the anti-CD20 antibody is administered to the patient repeatedly.

39. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient weekly.

40. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient weekly for about 2 to 10 weeks.

41. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient biweekly.

42. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient monthly.

43. A method according to claim 23 or 28, wherein the anti-CD20 antibody is administered to the patient parenterally.

44. A method according to claim 43, wherein the anti-CD20 antibody is administered to the patient by intravenous infusion.

45. A method according to claim 23 or 28, wherein the anti-CD20 antibody therapy and the chemotherapy are administered to the patient concurrently.

46. A method according to claim 23 or 28, wherein the chemotherapy comprises chlorambucil.

47. A method according to claim 23 or 28, wherein the chemotherapy comprises cyclophosphamide.

48. A method according to claim 47, wherein the chemotherapy comprises cyclophosphamide, vincristine, and prednisone (COP).

49. A method according to claim 47, wherein the chemotherapy comprises cyclophosphamide, vincristine, prednisone, and doxorubicin (CHOP).

50. A method according to claim 23 or 28, wherein the chemotherapy comprises vincristine.

51. A method according to claim 23 or 28, wherein the chemotherapy comprises prednisone.

52. A method according to claim 23 or 28, wherein the chemotherapy comprises doxorubicin.

53. A method according to claim 23 or 28, wherein the chemotherapy comprises fludarabine.

54. A method according to claim 23 or 28, wherein the chemotherapy comprises methotrexate.

55. A method according to claim 23 or 28, wherein the chemotherapy comprises cisplatin.

56. A method according to claim 23 or 28, wherein the chemotherapy comprises toremifene.

57. A method according to claim 23 or 28, wherein the chemotherapy comprises tamoxifen.

28. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 to about 1500 mg/m², wherein the anti-CD20 antibody therapy is combined with chemotherapy, and wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

29. A method according to claim 28, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 mg/m².

59. A method according to claim 6, 28, or 58, wherein radiation is not used in conjunction with the anti-CD20 antibody.

58. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the patient is refractory to fludarabine previously administered for the chronic lymphocytic leukemia, and wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

60. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering a therapeutic non-radiolabeled anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein radiation is not used in conjunction with said anti-CD20 antibody.