Subcutaneous injections of low-dose veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin's lymphoma

Haematologica

Volumn 96, Issue 4, 2011, Pages 567-573

  Negrea, George O ^a   Elstrom, Rebecca ^b   Allen, Steven L ^c   Rai, Kanti R ^d   Abbasi, Rashid M ^e   Farber, Charles M ^f   Teoh, Nick ^g   Horne, Heather ^g   Wegener, William A ^g   Goldenberg, David M ^g,h  

^a Low Country Cancer Care Associates   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c NORTH SHORE UNIVERSITY HOSPITAL   (United States)

^d LONG ISLAND JEWISH MEDICAL CENTER   (United States)

^e Hematology Oncology Specialists   (United States)

^f Carol G Simon Cancer Center   (United States)

^g IMMUNOMEDICS INC   (United States)

^h CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY   (United States)

Author keywords

Antibody; CD20; hA20; Non Hodgkin's lymphoma; Subcutaneous therapy

Indexed keywords

IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; VELTUZUMAB;

ADULT; AGED; ANTIBODY TITER; AREA UNDER THE CURVE; ARTICLE; B LYMPHOCYTE; CHILL; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FEMALE; FOLLICULAR LYMPHOMA; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE REDNESS; INJECTION SITE TENDERNESS; LIMB PAIN; LOW DRUG DOSE; LYMPHOCYTOMA; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; OPEN STUDY; PAIN; PHASE 1 CLINICAL TRIAL; PILOT STUDY; SINUS INFECTION; SPLENIC MARGINAL ZONE LYMPHOMA; SUSTAINED DRUG RELEASE; T LYMPHOCYTE; THORAX PAIN; TIME TO MAXIMUM PLASMA CONCENTRATION; TONGUE SWELLING; UPPER RESPIRATORY TRACT INFECTION;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIGENS, CD20; ANTINEOPLASTIC AGENTS; FEMALE; HEMATOLOGIC TESTS; HUMANS; INJECTIONS, SUBCUTANEOUS; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; NEOPLASM STAGING; TREATMENT OUTCOME;

EID: 79953883456     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2010.037390     Document Type: Article

References (40)

1. McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998;16:(8)2825-2833.
2. Traullé C, Coiffier BB. Evolving role of rit-uximab in the treatment of patients with non-Hodgkin's lymphoma. Future Oncol. 2005;1(3):297-306.
3. Marcus R, Hagenbeek A. The therapeutic use of rituximab in non-Hodgkin's lymphoma. Eur J Haematol Suppl. 2007;(67):5-14.
4. Cheung MC, Haynes AE, Meyer RM, Stevens A, Imrie KR; Members of the Hematology, Disease Site Group of the Cancer Care Ontario Program in Evidence-Based Care. Rituximab in lymphoma: a systematic review and consensus practice guideline from Cancer Care Ontario. Cancer Treat Rev. 2007;33(2):161-176.
5. Czuczman MS, Weaver R, Alkuzweny B, Berlfein J, Grillo-Lopez AJ. Prolonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin's lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-up. J Clin Oncol. 2004;22(23):4711-4716.
6. Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large B-cell lymphoma. N Engl J Med. 2002;346(4):235-242.
7. Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lym-phoma. J Clin Oncol. 2006;24(19):3121-3127.
8. Marcus R, Imrie K, Belch A, Cunningham D, Flores E, Catalano J, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105(4):1417-1423.
9. Hochster H, Weller E, Gascoyne RD, Habermann TM, Gordon LI, Ryan T, et al. Maintenance rituximab after cyclophos-phamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 Study. J Clin Oncol. 2009;27(10):1607-1614.
10. Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage fol-licular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005;106(12):3725-3732.
11. Chambers SA, Isenberg D. Anti-B cell therapy (rituximab) in the treatment of autoimmune diseases. Lupus. 2005;14(3):210-214.
12. Silverman GJ. Anti-CD20 therapy and autoimmune disease: therapeutic opportunities and evolving insights. Front Biosci. 2007;12:2194-2206.
13. Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806.
14. Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008; 358(7):676-688.
15. Dörner T, Burmester GR. New approaches of B-cell-directed therapy: beyond ritux-imab. Curr Opin Rheumatol. 2008;20(3): 263-268.
16. Martin P, Furman RR, Ruan J, Elstrom R, Barrientos J, Niesvizky R, et al. Novel and engineered anti-B-cell monoclonal antibodies for non-Hodgkin's lymphoma. Semin Hematol. 2008;45(2):126-32.
17. Czuczman MS, Gregory SA. The future of CD20 monoclonal antibody therapy in B-cell malignancies. Leuk Lymphoma. 2010;51(6):983-994.
18. Genovese MC, Kaine JL,Lowenstein MB,Giudice JD, Baldassare A, Schechtman J, et al. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008;58(9):2652-2661.
19. Morschhauser F, Marlton P, Vitolo U, Lindén O, Seymour JF, Crump M, et al. Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/ refractory follicular lymphoma. Ann Oncol. 2010;21(9):1870-1876.
20. Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase I/II trial. Blood. 2008;111(12):5486-5495.
21. Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, et al. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. 2008;111(3):1094-1100.
22. Robak T. GA-101, a third-generation, humanized and glycol-engineered anti-CD20 mAb for the treatment of B-cell lym-phoid malignancies. Curr Opin Investig Drugs. 2009;10(6):588-596.
23. Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, et al. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004;10(8):2868-2878.
24. Goldenberg DM, Rossi EA, Stein R, Cardillo TM, Czuczman MS, Hernandez-Ilizaliturri FJ, et al. Properties and structure-function relationships of veltuzumab (hA20), a humanized anti-CD20 monoclonal antibody. Blood. 2009;113(5):1062-1070.
25. Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab, a novel humanized anti-CD20 monoclonal antibody: Characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010;51(5):747-755.
26. Milani C, Castillo J. Veltuzumab, an anti-CD20 mAb for the treatment of non-Hodgkin's lymphoma, chronic lymphocyt-ic leukemia and immune thrombocy-topenic purpura. Curr Opin Mol Ther. 2009;11(2):200-207.
27. Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, et al. Humanized anti-CD20 antibody, vel-tuzumab, in refractory/recurrent non-Hodgkin's lymphoma: Phase I/II results. J Clin Oncol. 2009;27(20):3346-3353.
28. Harris NL and Ferry JA. Classification of non-Hodgkin's lymphomas, in Knowles DM (ed): Neoplastic Hematopathology, 2nd ed. Philadelphia, PA. Lippincott Williams & Wilkins, 2001, pp 691-753.
29. Solal-Céligny P, Roy P, Colombat P, White J, Armitage JO, Arranz-Saez R, et al. Follicular lymphoma international prognostic index. Blood. 2004;104(5):1258-1265.
30. Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lym-phomas. J Clin Oncol. 1999;17(4):1244-1253.
31. Davis TA, Grillo-López AJ, White CA, McLaughlin P, Czuczman MS, Link BK, et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lym-phoma: Safety and efficacy of re-treatment. J Clin Oncol. 2000;18(17):3135-3143.
32. Negrea OG, Allen SL, Rai KR, Elstrom R, Abbasi MR, Farber CM, et al. Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab for treatment of indolent B-cell malignancies. Blood. 2009;114(22):1446 (abstr 3757).
33. Cartron G, Blasco H, Paintaud G, Watier H, Le Guellec C. Pharmacokinetics of ritux-imab and its clinical use: thought for the best use? Crit Rev in Oncol Hematol. 2007;62(1):43-52.
34. Berinstein NL, Grillo-López AJ, White CA, Bence-Bruckler I, Maloney D, Czuczman M, et al. Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lym-phoma. Ann Oncol. 1998;9(9):995-1001.
35. Glennie MJ, French RR, Cragg MS, Taylor RP. Mechanisms of killing by anti-CD20 monoclonal antibodies. Mol Immunol. 2007;44(16):3823-3837.
36. Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, et al. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994;84(8):2457-2466.
37. Maloney DG, Grillo-López AJ, Bodkin DJ, White CA, Liles TM, Royston I, et al. IDEC-C2B8: Results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma, relapsed low-grade or follicular B-cell lymphoma. J Clin Oncol. 1997;15(10):3266-3274.
38. Provan D, Butler T, Evangelista ML, Amadori S, Newland AC, Stasi R. Activity and safety profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults. Haematologica. 2007;92(12):1695-1698.
39. Aue G, Lindorfer MA, Beum PV, Pawluczkowycz AW, Vire B, Hughes T, et al. Fractionated subcutaneous rituximab is well-tolerated and preserves CD20 expression on tumor cells in patients with chronic lymphocytic leukemia. Haematologica. 2010;95(2):329-332.
40. Saleh MN, Liebman H, Bernstein ZP, Negrea OG, Bussel JB, Onyegbula AC, et al. Subcutaneous injections of low-dose anti-CD20 veltuzumab for treatment of relapsed immune thrombocytopenia (ITP). Blood. 2009;114(22):541(abstr 1322).