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

References

• Jemal A, Siegel R, Ward E, et al Cancer statistics, 2008. CA Cancer J Clin 2008;58:71–96.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. SEER Cancer Statistics Review, 1975–2005. Bethesda, MD: National Cancer Institute; 2008.
   Google Scholar
• Hsi ED, Frater JL. Advances in the diagnosis and classification of chronic lymphoproliferative disorders. Cancer Treat Res 2004;121:145–165.
   PubMedGoogle Scholar
• Zent CS, Kay NE. Advances in the understanding of biology and prognosis in chronic lymphocytic leukemia. Curr Oncol Rep 2004;6:348–354.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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 CHOP-like regimen as second line therapy. Haematologica 2001;86:1165–1171.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Huhn D, von Schilling C, Wilhelm M, et al Rituximab therapy of patients with B-cell chronic lymphocytic leukemia. Blood 2001;98:1326–1331.
   PubMed Web of Science ®Google Scholar
• 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).
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Tong AW, Stone MJ. Prospects for CD40-directed experimental therapy of human cancer. Cancer Gene Ther 2003;10:1–13.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hussein MA, 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).
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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).
   Web of Science ®Google Scholar
• Rituxan (Rituximab) prescribing information. 2008. Available from: http://www.rituxan.com/. Accessed 20 September 2008.
   Google Scholar
• Alemtuzumab (Campath) prescribing information. 2008. Available from: http://www.fda.gov/CDER/foi/label/2001/alemmil050701LB.htm. Accessed 17 December 2008.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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).
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar