A phase I study of dacetuzumab (SGN-40, a humanized anti-CD40 monoclonal antibody) in patients with chronic lymphocytic leukemia

Leukemia and Lymphoma

Volumn 51, Issue 2, 2010, Pages 228-235

  Furman, Richard R ^a   Forero Torres, Andres ^b   Shustov, Andrei ^c   Drachman, Jonathan G ^d  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d SEATTLE GENETICS INC   (United States)

Author keywords

CD40; Chronic lymphocytic leukemia; Clinical trial; Dacetuzumab; Monoclonal antibody; SGN 40

Indexed keywords

SGN 40;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER CHEMOTHERAPY; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONJUNCTIVITIS; DEATH; DRUG DOSE ESCALATION; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERHIDROSIS; MALE; NIGHT SWEAT; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANOREXIA; ANTIBODIES, MONOCLONAL; CONJUNCTIVITIS; DOSE-RESPONSE RELATIONSHIP, DRUG; FATIGUE; FEMALE; HEADACHE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 76349120845     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428190903440946     Document Type: Article

References (31)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008;58:71-96.
2. National Cancer Institute. SEER Cancer Statistics Review, 1975-2005. Bethesda, MD: National Cancer Institute; 2008.
3. Hsi ED, Frater JL. Advances in the diagnosis and classification of chronic lymphoproliferative disorders. Cancer Treat Res 2004;121:145-165.
4. Zent CS, Kay NE. Advances in the understanding of biology and prognosis in chronic lymphocytic leukemia. Curr Oncol Rep 2004;6:348-354.
5. Byrd JC, Rai K, Peterson BL, et al. Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood 2005;105:49-53.
6. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol 2005;23:4079-4088. (Pubitemid 46211313)
7. Tam CS, O'Brien S, Lerner S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leuk Lymphoma 2007;48:1931-1939.
8. Rai KR, Peterson BL, Appelbaum FR, et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med 2000;343:1750-1757.
9. Stelitano C, Morabito F, Kropp MG, et al. Fludarabine treatment in B-cell chronic lymphocytic leukemia: response, toxicity and survival analysis in 47 cases. Haematologica 1999;84:317-323.
10. Liso V, Molica S, Capalbo S, et al. Response to fludarabine in B-cell chronic lymphocytic leukemia patients previously treated with chlorambucil as up-front therapy and a CHOPlike regimen as second line therapy. Haematologica 2001;86: 1165-1171.
11. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol 2007;25:5616-5623.
12. Lissitchkov T, Arnaudov G, Peytchev D, Merkle K. Phase-I/II study to evaluate dose limiting toxicity, maximum tolerated dose, and tolerability of bendamustine HCl in pre-treated patients with B-chronic lymphocytic leukaemia (Binet stages B and C) requiring therapy. J Cancer Res Clin Oncol 2006;132:99-104.
13. Huhn D, von Schilling C, Wilhelm M, et al. Rituximab therapy of patients with B-cell chronic lymphocytic leukemia. Blood 2001;98:1326-1331.
14. Hallek M, Fingerle-Rowson G, Fink A-M, et al. Immunochemotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) versus fludarabine and cyclophosphamide (FC) improves response rates and progression-free survival (PFS) of previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL). Blood 2008;112:125 (Abstract 325).
15. Wierda W, O'Brien S, Wen S, et al. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol 2005;23:4070-4078. (Pubitemid 46211312)
16. Tong AW, StoneMJ. Prospects for CD40-directed experimental therapy of human cancer. Cancer Gene Ther 2003;10:1-13.
17. Law CL, Gordon KA, Collier J, et al. Preclinical antilymphoma activity of a humanized anti-CD40 monoclonal antibody, SGN-40. Cancer Res 2005;65:8331-8338.
18. von Bergwelt-Baildon M, Maecker B, Schultze J, Gribben JG. CD40 activation: potential for specific immunotherapy in B-CLL. Ann Oncol 2004;15:853-857.
19. Harris NL, Jaffe ES, Diebold J, et al. The World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues. Report of the Clinical Advisory Committee meeting, Airlie House, Virginia, November, 1997. Ann Oncol 1999;10:1419-1432.
20. Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996;87:4990-4997.
21. HusseinMA, Berenson JR, Niesvizky R, et al. Results of a phase I trial of SGN-40 (anti-huCD40 mAb) in patients with relapsed multiple myeloma. Blood 2006;108:365s (Abstract 3576).
22. Heintel D, Schwarzinger I, Chizzali-Bonfadin C, et al. Association of CD38 antigen expression with other prognostic parameters in early stages of chronic lymphocytic leukemia. Leuk Lymphoma 2001;42:1315-1321.
23. Tsimberidou AM, Tam C, Wierda W, et al. Beta-2 microglobulin (B2M) is an independent prognostic factor for clinical outcomes in patients with CLL treated with frontline fludarabine, cyclophosphamide, and rituximab (FCR) regardless of age, creatinine clearance (CrCl), or performance status (PS). J Clin Oncol 2007;25:365s (Abstract 7034).
24. Rituxan (Rituximab) prescribing information. 2008. Available from: http://www.rituxan.com/. Accessed 20 September 2008.
25. Alemtuzumab (Campath) prescribing information. 2008. Available from: http://www.fda.gov/CDER/foi/label/2001/ alemmil050701LB.htm. Accessed 17 December 2008.
26. Damle RN, Ghiotto F, Valetto A, et al. B-cell chronic lymphocytic leukemia cells express a surface membrane phenotype of activated, antigen-experienced B lymphocytes. Blood 2002;99:4087-4093.
27. Yellin MJ, Sinning J, Covey LR, et al. T lymphocyte T cell-B cell-activating molecule/CD40-L molecules induce normal B cells or chronic lymphocytic leukemia B cells to express CD80 (B7/BB-1) and enhance their costimulatory activity. J Immunol 1994;153:666-674.
28. Gricks CS, Zahrieh D, Zauls AJ, et al. Differential regulation of gene expression following CD40 activation of leukemic compared to healthy B cells. Blood 2004;104: 4002-4009.
29. Bourcier T, De Saint-Jean M, Brignole F, et al. Expression of CD40 and CD40 ligand in the human conjunctival epithelium. Invest Ophthalmol Vis Sci 2000;41:120-126.
30. Hussein MA, Berenson JR, Niesvizky R, et al. A phase I humanized anti-CD40 monoclonal antibody (SGN-40) in patients with multiple myeloma. Blood 2005;106:723a (Abstract 2572).
31. Advani R, Forero-Torres A, Furman RR, et al. Phase I study of the humanized anti-CD40 monoclonal antibody dacetuzumab in refractory or recurrent non-Hodgkin's lymphoms. J Clin Oncol 2009;27:4371-4377.