• Giuseppe Tridente


Alemtuzumab (Campath®, MabCampath®, Genzyme) is an IgG1k anti-CD52 humanized monoclonal antibody (mAb) that was first licensed in March 2001 by FDA. EMEA granted its approval in July 2001 and Health Canada in November 2005. The initial indication was limited to B-CLL previously treated and resistant to alkylating agents. Starting from 2007, alemtuzumab was approved also as first-line therapy of B-CLL. So far, it has been experienced in over 60 countries.


Progressive Multifocal Leukoencephalopathy Infusion Reaction Progressive Multifocal Leukoencephalopathy Tumor Lysis Syndrome Cytokine Release Syndrome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Supplementary material

307171_1_En_7_MOESM1_ESM.xls (59 kb)
Supplementary material 1 (XLS 60 kb)


  1. 1.
    BLA 99-0786 (FDA) Application No. 103948/0, Campath®, (Alemtuzumab) Medical Review (2001)Google Scholar
  2. 2.
    Campath® (Alemtuzumab) Package Insert (PI) (2001)Google Scholar
  3. 3.
    BLA 103948/5070 (FDA) New Drug Application (NDA) Review (2007)Google Scholar
  4. 4.
    Campath ®(Alemtuzumab) PI (2007)Google Scholar
  5. 5.
    WC500025264 (EMA) MabCampath® (Alemtuzumab). Scientific Discussion (2005)Google Scholar
  6. 6.
    MabCampath® (Alemtuzumab). Product Monograph (PM) Appl. No. 134666 Health Canada (2010)Google Scholar
  7. 7.
    CAMPATH-1H (Alemtuzumab) BLA 103948/0 Clin Pharmacol Review, FDA (2001)Google Scholar
  8. 8.
    Mould DR, Baumann A, Kuhlmann J et al (2007) Population pharmacokinetics–pharmacodynamics of alemtuzumab (Campath®) in patients with chronic lymphocytic leukemia and its link to treatment response. Br J Clin Pharmacol 64:278–291PubMedCrossRefGoogle Scholar
  9. 9.
    Hale G, Rebello P, Brettman LR et al (2004) Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood 104:948–955PubMedCrossRefGoogle Scholar
  10. 10.
    Dearden CE, Khot A, Else M et al (2011) Alemtuzumab therapy in T-cell prolymphocytic leukemia: comparing efficacy in a series treated intravenously and a study piloting the subcutaneous route. Blood 118:5799–5802PubMedCrossRefGoogle Scholar
  11. 11.
    Lundin J, Kimby E, Bjorkholm M et al (2002) Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood 100:768–773PubMedCrossRefGoogle Scholar
  12. 12.
    Stilgenbauer S, Zenz T, Winkler D et al (2009) Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol 27:3994–4001PubMedCrossRefGoogle Scholar
  13. 13.
    Martin S, Marty FM, Fiumara K et al (2006) Infectious complications associated with alemtuzumab use in lymphoproliferative disorders. Clin Infect Dis 43:16–24PubMedCrossRefGoogle Scholar
  14. 14.
    Treleaven J, Gennery A, Marsh J et al (2010) Guidelines on the use of irradiated blood components prepared by the British Committee for Standards in Haematology. BJH 152:35–51 (rev. 2011 no change)Google Scholar
  15. 15.
    Hillmen P, Skotnicki AB, Robak T et al (2007) Alemtuzumab compared to chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol 25:5616–5623PubMedCrossRefGoogle Scholar
  16. 16.
    Oscier D, Dearden C, Erem E et al (2012) Guidelines on the diagnosis, investigation and management of chronic lymphocytic leukaemia. (
  17. 17.
    Alemtuzumab. CCO Drug Formulary Feb. 2012 (
  18. 18.
    Paul RN, Alizadeh L, Ajavi OI et al (2012) A case report of T cell prolymphocytic leukemia and Kaposi sarcoma and a review of T cell prolymphocytic leukemia. Acta Haematol 127:235–243PubMedCrossRefGoogle Scholar
  19. 19.
    Fraser G, Haynes AE, Kouroukis CT et al (2007) Alemtuzumab for the treatment of T-cell prolymphocytic leukemia. CED-CCO, PEBC Advise Report 6–22 (
  20. 20.
    Dearden C (2012) How I treat prolymphocytic leukemia. Blood 120:538–551Google Scholar
  21. 21.
    Enblad L, Hagberg H, Erlanson M et al (2004) A pilot study of alemtuzumab (anti-CD52 monoclonal antibody) therapy for patients with relapsed or chemotherapy-refractory peripheral T-cell lymphomas. Blood 103:2920–2924PubMedCrossRefGoogle Scholar
  22. 22.
    Kluin-Nelemans HC, Marwijk Koov van M, Lugtenburg PJ et al (2011) Intensified alemtuzumab-CHOP therapy for peripheral T-cell lymphoma. Ann Oncol 22:1595–1600Google Scholar
  23. 23.
    Loh Y, Ovama Y, Statkute L et al (2007) Development of a secondary autoimmune disorder after hematopoietic stem cell transplantation for autoimmune diseases: role of conditioning regimen used. Blood 109:2548–2643CrossRefGoogle Scholar
  24. 24.
    Agarwal A, Bruno D, Knechtle SJ (2010) The role of alemtuzumab in solid organ transplantation. In: Kaplan B et al (eds) Immunotherapy in Transplantation: principles and practice. Wiley-Blackwell, OxfordGoogle Scholar
  25. 25.
    Watson CJE, Bradley JA, Friend PJ et al (2005) Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation—efficacy and safety at five years transplantation. Am J Transpl 5:1347–1353CrossRefGoogle Scholar
  26. 26.
    Hanaway MJ, Woodle ES, Mulgaonkar S et al (2011) Alemtuzumab induction in renal transplantation. New Engl J Med 364:1909–1919PubMedCrossRefGoogle Scholar
  27. 27.
    Safdar N, Smith J, Knasinski V et al (2010) Infections after use of alemtuzumab in solid organ transplant recipients: a comparative study. Diagn Microbiol Infect Dis 66:7–15PubMedCrossRefGoogle Scholar
  28. 28.
    Morgan RD, O’Callaghan JM, Knight SR et al (2012) Alemtuzumab induction therapy in kidney transplantation: a systemic review and meta-analysis. Transplantation 93:1179–1188PubMedCrossRefGoogle Scholar
  29. 29.
    Elimelak M, Dayton V, Park KS et al (2007) Red cell aplasia and autoimmune hemolytic anemia following immunosuppression with alemtuzumab, mycophenolate, and daclizumab in pancreas transplant recipients. Haematologica 92:1029–1036CrossRefGoogle Scholar
  30. 30.
    Marcos A, Eghtesad B, Fung JJ et al (2004) Use of alemtuzumab and tacrolimus monotherapy for cadaveric liver transplantation: with particular reference to hepatitis C virus. Transplantation 78:966–971PubMedCrossRefGoogle Scholar
  31. 31.
    Heiligenhaus A, Thurau S, Hennig M et al (2010) Anti-inflammatory treatment of uveitis with biologicals: new treatment options that reflect pathogenetic knowledge of the disease. Graefes Arch Clin Exp Ophthalmol 248:1531–1551PubMedCrossRefGoogle Scholar
  32. 32.
    Lockwood CM, Hale G, Waldman H et al (2003) Remission induction in Behçet’s disease following lymphocyte depletion by the anti CD52 antibody CAMPATH 1-H. Rheumatology 42:1539–1544Google Scholar
  33. 33.
    Smith RM, Chow YW, Jayne DRW (2010) Alemtuzumab (CAMPATH 1H) as remission induction therapy in Bechet’s disease, [abstract]. Arthritis Rheum 62(10):1278Google Scholar
  34. 34.
    Marsh EA, Hirst CL, Llewelyn JG et al (2010) Alemtuzumab in the treatment of IVIG-dependent chronic inflammatory demyelinating polyneuropathy. J Neurol 257:913–919PubMedCrossRefGoogle Scholar
  35. 35.
    Anderson AE, Lorenzi AR, Pratt A et al (2012) Immunity 12 years after alemtuzumab in RA: CD5+ B-cell depletion, thymus-dependent T-cell reconstitution and normal vaccine response. Rheumatology 51:1397–1406PubMedCrossRefGoogle Scholar
  36. 36.
    Cohen JA, Coles AJ, Arnold D et al (2012) Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomized controlled phase 3 trial. Lancet 380:1819–1828PubMedCrossRefGoogle Scholar
  37. 37.
    Cossburn M, Pace AA, Jones J et al (2011) Autoimmune disease after alemtuzumab for multiple sclerosis in a multicenter cohort. Neurology 77:573–579PubMedCrossRefGoogle Scholar
  38. 38.
    Cuker A, Coles AJ, Sullivan H et al (2011) A distinctive form of immune thrombocytopenia in a phase 2 study of alemtuzumab fir the treatment of relapsing-remitting multiple sclerosis. Blood 118:6299–6305PubMedCrossRefGoogle Scholar
  39. 39.
    Jones JL, Phuah CL, Cox AL et al (2009) IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (Campath-1H). J Clin Invest 119:2052–2061PubMedGoogle Scholar

Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

Personalised recommendations