Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody

• US 6,455,043 B1
• Filed: 08/11/1999
• Issued: 09/24/2002
• Est. Priority Date: 08/11/1998
• Status: Expired due to Term

• Current Assignee: Biogen, Inc.
• Original Assignee: IDEC Pharmaceuticals Corporation (Biogen, Inc.)
• Inventors: Grillo-López, Antonio J.
• Primary Examiner(s): Hartley, Michael G.
• Application Number:
  US09/372,202
• Time in Patent Office: 1,140 Days
• Field of Search: 424/1.49, 424/133.1, 424/143.1, 424/144.1, 424/156.1, 424/174.1, 424/153.1, 530/387.3, 530/388.22, 530/388.73, 530/388.8, 530/388.85, 530/391.3
• US Class Current: 424/155.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• 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 31/475 having an indole ring, e.g. yohimbine, reserpine, strychnine, vinblastine vincamine A61K31/4375
• 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 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/2013 IL-2
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 38/217 IFN-gamma
• CPC Class Codes: A61K 39/39541 against normal tissues, cells
• CPC Class Codes: A61K 39/39558 against tumor tissues, cells, antigens
• CPC Class Codes: A61K 51/1027 against receptors, cell-surface antigens or cell-surface determinants
• CPC Class Codes: A61K 51/1069 the tumor cell being from blood cells, e.g. the cancer being a myeloma
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C02F 1/003 : using household-type filters for producing potable water, e.g. pitchers, bottles, faucet mounted devices C02F9/20 takes precedence
• CPC Class Codes: C02F 2307/02 : as part of a bottle
• CPC Class Codes: C07K 16/2887 : against CD20
• CPC Class Codes: C07K 16/3061 : Blood cells
• CPC Class Codes: C07K 2317/24 : containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/56 : variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/77 : Internalization into the cell

Abstract

New combined therapeutic regimens for treatment of B-cell lymphomas are disclosed which comprise in particular administration of anti-CD20 antibodies to patients having low-, intermediate- or high-grade non-Hodgkins lymphomas.

Claims

1. A method for reducing residual CD20+ tumor cells in bone marrow or stem cell tissue after myeloablative therapy in a subject in need of such treatment by administering an amount of a non-radiolabeled anti-CD20 antibody effective to reduce the number of residual CD20+ tumor cells in said bone marrow or stem cell tissue.

2. The method of claim 1 wherein said anti-CD20+ antibody comprises human IgGl constant regions.

3. The method of claim 1 wherein said antibody is a chimeric anti-CD20 antibody.

4. The method of claim 3 wherein said antibody is C2B8.

5. The method of myeloablative claim 1 wherein the treated subject had B cell lymphoma.

6. The method of claim 5 wherein said B cell lymphoma is selected from the group consisting of low grade/follicular non-Hodgkin'"'"'s lymphoma (NHL), small lymphocytic (SL) NHL, intermediate grade/follicular NHL, intermediate grade diffuse NHL, chronic lymphocytic leukemia (CLL), high grade immunoblastic NHL, high grade lymphoblastic NHL, high grade small non-cleaved cell NHL, bulky disease NHL, mantle cell lymphoma, AIDS-related lymphoma and Waldenstrom'"'"'s Macroglobulinemia.

7. The method of claim 3 wherein the treated subject has low grade, intermediate grade or high-grade lymphoma.

8. The method of claim 3 wherein the treated subject has stage I, stage II, stage III or stage IV non-Hodgkin'"'"'s lymphoma.

9. The method of claim 3 wherein myeloablative therapy is effected using Y2B8.

10. The method of claim 3 wherein the treated subject has relapsed after myeloablative therapy.

11. The method of claim 1, further comprising administering at least one chemotherapeutic agent.

12. The method of claim 2 wherein the anti-CD20 antibody is C2B8 which is administered at a dosage ranging from 10-500 mg/m².

13. The method of claim 12 wherein the antibody is administered by infusion.

14. The method of claim 12 wherein at a dosage of about 375 mg/m².

15. The method of claim 14 wherein said antibody dosage is administered weekly.