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

Volumn 111, Issue 3, 2008, Pages 1094-1100

  Coiffier, Bertrand ^a   Lepretre, Stéphane ^b   Pedersen, Lars Møller ^c   Gadeberg, Ole ^d   Fredriksen, Henrik ^e   Van Oers, Marinus H J ^f   Wooldridge, James ^g   Kloczko, Janusz ^h   Holowiecki, Jerzy ⁱ   Hellmann, Andrzej ^j   Walewski, Jan ^k   Flensburg, Mimi ^l   Petersen, Jørgen ^l   Robak, Tadeusz ^m  

^a CENTRE HOSPITALIER LYON SUD   (France)

^b CENTRE HENRI BECQUEREL   (France)

^c GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^d LILLEBAELT HOSPITAL   (Denmark)

^e ODENSE UNIVERSITY HOSPITAL   (Denmark)

^f UNIVERSITY OF AMSTERDAM   (Netherlands)

^g UNIVERSITY OF IOWA   (United States)

^h Klinika Hematologii   (Poland)

ⁱ Uniwersytetu Medycznego w   (Poland)

^j MEDICAL UNIVERSITY OF GDANSK   (Poland)

^k INSTITUTE OF ONCOLOGY   (Poland)

^l Genmab   (Denmark)

^m MEDICAL UNIVERSITY OF LODZ   (Poland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CD20 ANTIBODY; OFATUMUMAB;

ADULT; AGED; ANGINA PECTORIS; ARTICLE; B CELL LEUKEMIA; CANCER RELAPSE; CAROTID ARTERY OBSTRUCTION; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED STUDY; CYTOLYTIC HEPATITIS; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMOGLOBIN BLOOD LEVEL; HEMOLYTIC ANEMIA; HERPES ZOSTER; HUMAN; INTERSTITIAL LUNG DISEASE; INTERSTITIAL PNEUMONIA; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SINUSITIS;

EID: 38949185742     PISSN: 00064971     EISSN: 00064971     Source Type: Journal    
DOI: 10.1182/blood-2007-09-111781     Document Type: Article

References (29)

1. Brugiatelli M, Bandini G, Barosi G, et al. Management of chronic lymphocytic leukemia: practice guidelines from the Italian Society of Hematology, the Italian Society of Experimental Hematology and the Italian Group for Bone Marrow Transplantation. Haematologica. 2006;91:1662-1673.
2. O'Brien S. Treatment of chronic lymphocytic leukemia. In: American Society of Clinical Oncology - 2007 Educational Book. 2007;367-372.
3. Kasamon YL, Flinn IW. Management of symptomatic, untreated chronic lymphocytic leukemia. Blood Rev. 2007;21:143-156.
4. 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.
5. 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.
6. Wierda W, O'Brien S, Faderl S, et al. A retrospective comparison of three sequential groups of patients with recurrent/refractory chronic lymphocytic leukemia treated with fludarabine-based regimens. Cancer. 2006;106:337-345.
7. Byrd JC, Peterson BL, Morrison VA, et al. Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood. 2003;101:6-14.
8. Wierda WG. Current and investigational therapies for patients with CLL. Hematology Am Soc Hematol Educ Program. 2006;285-294.
9. Byrd JC, Murphy T, Howard RS, et al. Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol. 2001;19:2153-2164.
10. Nabhan C. The emerging role of alemtuzumab in chronic lymphocytic leukemia. Clin Lymphoma Myeloma. 2005;6:115-121.
11. Thursky KA, Worth LJ, Seymour JF, Miles Prince H, Slavin MA. Spectrum of infection, risk and recommendations for prophylaxis and screening among patients with lymphoproliferative disorders treated with alemtuzumab. Br J Haematol. 2006;132:3-12.
12. Golay J, Lazzari M, Facchinetti V, et al. CD20 levels determine the in vitro susceptibility to rituximab and complement of B-cell chronic lymphocytic leukemia: further regulation by CD55 and CD59. Blood. 2001;98:3383-3389.
13. Bannerji R, Kitada S, Flinn IW, et al. Apoptoticregulatory and complement-protecting protein expression in chronic lymphocytic leukemia: relationship to in vivo rituximab resistance. J Clin Oncol. 2003;21:1466-1471.
14. Saphire EO, Stanfield RL, Crispin MD, et al. Contrasting IgG structures reveal extreme asymmetry and flexibility. J Mol Biol. 2002;319:9-18.
15. Dahlke MH, Larsen SR, Rasko JE, Schlitt HJ. The biology of CD45 and its use as a therapeutic target. Leuk Lymphoma. 2004;45:229-236.
16. Teeling JL, French RR, Cragg MS, et al. Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood. 2004;104:1793-1800.
17. Teeling JL, Mackus WJ, Wiegman LJ, et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol. 2006;177:362-371.
18. Cheson BD, Bennett JM, Rai KR, et al. Guidelines for clinical protocols for chronic lymphocytic leukemia: recommendations of the National Cancer Institute-sponsored working group. Am J Hematol. 1988;29:152-163.
19. 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.
20. Huhn D, von Schilling C, Wilhelm M, et al. Rituximab therapy of patients with B-cell chronic lymphocytic leukemia. Blood. 2001;98:1326-1331.
21. Itala M, Geisler CH, Kimby E, et al. Standard-dose anti-CD20 antibody rituximab has efficacy in chronic lymphocytic leukaemia: results from a Nordic multicentre study. Eur J Haematol. 2002;69:129-134.
22. Hainsworth JD, Litchy S, Barton JH, et al. Single-agent rituximab as first-line and maintenance treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol. 2003;21:1746-1751.
23. O'Brien SM, Kantarjian H, Thomas DA, et al. Rituximab dose-escalation trial in chronic lymphocytic leukemia. J Clin Oncol. 2001;19:2165-2170.
24. Hagenbeek A, Radford JA, Plesner T, et al. HuMax-CD20, A novel fully human anti-CD20 monoclonal antibody: results of a phase I/II trial in relapsed or refractory follicular non-Hodgkin's lymphoma. Blood. 2005;106:Abstract 4760.
25. Kimby E. Tolerability and safety of rituximab (MabThera). Cancer Treat Rev. 2005;31:456-473.
26. Osterborg A, Karlsson C, Lundin J, Kimby E, Mellstedt H. Strategies in the management of alemtuzumab-related side effects. Semin Oncol. 2006;33:S29-S35.
27. Anaissie EJ, Kontoyiannis DP, Obrien S, et al. Infections in patients with chronic lymphocytic leukemia treated with fludarabine. Ann Intern Med. 1998;129:559-566.
28. Ghielmini M, Rufibach K, Salles G, et al. Single agent rituximab in patients with follicular or mantle cell lymphoma: clinical and biological factors that are predictive of response and event-free survival as well as the effect of rituximab on the immune system: a study of the Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol. 2005;16:1675-1682.
29. Lemieux B, Tartas S, Traulle C, et al. Rituximab-related late-onset neutropenia after autologous stem cell transplantation for aggressive non-Hodgkin's lymphoma. BM Transplant. 2004;33:921-923.