B-cell chronic lymphocytic leukemia. Part IV: Monoclonal antibody treatment options with alemtuzumab and rituximab

1. Leporrier M, Chevret S, Cazin B, et al. Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated

stage B and C chronic lymphocytic leukemia patients. French Cooperative Group on Chronic Lymphocytic Leukemia. Blood

2001; 98: 2319–2325.

2. Robak T. Therapy of chronic lymphocytic leukemia with purine nucleoside analogues. Drugs Aging 2005; 22: 983–1012.

3. Keating MJ, O’Brien S, Lerner S, et al. Long-term follow-up of patients with chronic lymphocytic leukemia (CLL) receiving fludarabine

regimens as initial therapy. Blood 1998; 92: 1165–1171.

4. Flinn IW, Jemiai Y, Bennett JM, et al. Fludarabine and cyclophosphamide achieves high complete response rate in patients with

previously untreated chronic lymphocytic leukemia. Blood 2001; 98: 633a.

5. Eichhorst B, Busch R, Hopfinger G, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of

younger patients with chronic lymphocytic leukemia. Blood 2006; 107: 885–891.

6. Gilleece MH, Dexter TM. Effect of campath – 1H antibody on human hematopoietic progenitors in vitro. Blood 1993; 82: 807–812.

7. Hale G. CD52 (Campath1). J Biol Regul Homeost Agents 2001; 15: 386 – 391.

8. Dyer MJS, Hale G, Marcus RE, Waldmann H. Effects of Campath- 1 antibodies in vivo in patients with lymphoid malignancies:

influence of antibody isotype. Blood 1989; 73: 1431–1439.

9. Riechmann L, Clark M, Waldmann H, Winter G. Reshaping human antibodies for therapy. Nature 1988; 332: 323–327.

10. Hale G, Dyer MJS, Clark MR, et al. Remission induction in non-Hodgkin’s lymphoma with reshaped human monoclonal antibody

Campath-1H. Lancet 1988; 2: 1394–1399.

11. Flynn JM, Byrd JC. Campath-1H monoclonal antibody therapy. Curr Opin Oncol 2000; 12: 574–581.

12. Rowan W, Tite J, Topley P, Brett SJ. Cross-linking of the Campath- 1 antigen (CD52) mediates growth inhibition in human Band

T-lymphoma cell lines, and subsequently emergence of CD52 – deficient cells. Immunology 1998; 95: 427–436.

13. Ginaldi L, De Martinis M, Matutes E, et al. Levels of expression of CD52 in normal and leukemic B and T cells: correlation with

in vivo therapeutic responses to Campath-1H. Leuk Res 1998; 22: 185–191.

14. Österborg A, Dyer MJ, Bunjes D, et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of Campath-1H treatment in chronic lymphocytic leukemia. J Clin Oncol 1997; 15: 1567–1574.

15. Rai KR, Freter CE, Mercier RJ, et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol 2002; 20: 3891–3897.

16. Keating MJ, Flinn I, Jain V, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood 2002; 99: 3554–3561.

17. Stilgenbauer S, Döhner H. Campath-1H induced complete remission of chronic lymphocytic leukemia despite p53 gene mutation and resistance to chemotherapy. N Engl J Med 2002; 347: 452–453.

18. Lozanski G, Nyla A, Flin IW, et al. Alemtuzumab is an effective therapy for chronic lymphocytic leukemia with p 53 mutations and deletions. Blood 2004; 103: 3278–3281.

19. Dyer MJS, Kelsey SM, Mackay HJ, et al. In vivo purging of residual disease in CLL with Campath-1H. Br J Haematol 1997; 97: 669–672.

20. Rai KR, Byrd JC, Peterson BL, Larson LA. A phase II trial of fludarabine followed by alemtuzumab (Campath-1H) in previously untreated chronic lymphocytic leukemia (CLL) patients with active disease: Cancer and Leukemia Group B (CALGB) study 19901. Blood 2002; 100: 205a.

21. Moreton P, Kennedy B, Lucas M, et al. Eradication of minimal residual disease in B-cell chronic lymphocytic leukemia after alemtuzumab therapy is associated with prolonged survival. J Clin Oncol 2005; 23: 2971–2979.

22. Montillo M, Tedeschi A, Miqueleiz S, et al. Alemtuzumab as consolidation after a response to fludarabine is effective in purging residual disease in patients with chronic lymphocytic leukemia. J Clin Oncol 2006; 24: 2337–2342.

23. Montillo M, Cafro AM, Tedeschi A, et al. Safety and efficacy of subcutaneous Campath-1H for untreating residual disease in patients with chronic lymphocytic leukemia responding to fludarabine. Haematologica 2002; 87: 695–700.

24. Bowen AL, Zomas A, Emmett E, et al. Subcutaneous Campath- 1H in fludarabine-resistant/relapsed chronic lymphocytic and Bprolymphocytic leukaemia. Br J Haematol 1997; 96: 617–619.

25. Stilgenbauer S, Winkler D, Krober A, et al. Subcutaneous Campath- 1H (alemtuzumab) in fludarabine-refractory CLL; interim analysis of the CLL2H study of the German CLL Study Group (GCLLSG). Blood 2004; 104: 478a.

26. Lundin J, Kimby E, Björkholm M, et al. 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 2002; 100: 768–773.

27. Kennedy B, Rawstron A, Carter C, et al. Campath-1H and fludarabine in combination are highly active in refractory chronic lymphocytic leukemia. Blood 2002; 99: 2245–2247.

28. Elter T, Bochmann P, Schulz H, et al. FluCam – a new, 4-weekly combination of fludarabine and alemtuzumab for patients with relapsed chronic lymphocytic leukemia. Blood 2004; 104: 2517a.

29. Thursky KA, Worth LJ, Seymour JF, et al. Spectrum of infection, risk and recommendations for prophylaxis and screening among patients with lymphoproliferative disorders treated with alemtuzumab. Br J Haematol 2005; 132: 3–12.

30. Keating M, Coutré S, Rai K, et al. Management guidelines for use of alemtuzumab in B-cell chronic lymphocytic leukemia. Clin Lymphoma 2004; 4: 220–227.

31. Stashenko P, Nadler LM, Hardy R, et al. Characterization of a human B lymphocyte-specific antigen. J Immunol 1980; 125: 1678–1685.

32. Deans JP, Li H, Polyak MJ. CD20-mediated apoptosis: signaling through lipid rafts. Immunology 2002; 107: 176–182.

33. Anderson KC, Bates MP, Slaughenhoupt BL, et al. Expression of human B cell-associated antigens on leukemias and ymphomas: a model of human B cell differentiation. Blood 1984; 63:

1424–1433.

34. 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.

35. Press OW, Appelbaum F, Ledbetter JA, et al. Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B cell lymphomas. Blood 1987; 69: 584–591.

36. Grillo – López AJ, White CA, Varns C, et al. Overview of the clinical development of rituximab: first monoclonal antibody approved for the treatment of lymphoma. Semin. Oncol. 1999; 5 (Suppl. 14): 66–73.

37. Alas S, Emmanouilides S, Bonavida B, et al. Inhibition of interleukin- 10 by rituximab results in down – regulation of bcl-2 and senzitization of B-cell non-Hodgkin’s lymphoma to apoptosis. Clin. Cancer Res. 2001; 7: 709–723.

38. Di Gaetano N, Xiao Y, Erba E, et al. Synergism between fludarabine and rituximab revealed in a follicular lymphoma cell line resistant to the cytotoxic activity of either drug alone. Br J Haematol 2001; 114: 800–809.

39. McLaughlin P, Grillo-Lopez AJ, Link BK, 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: 2825–2833.

40. Lin TS, Byrd JC. Monoclonal antibody therapy in lymphoid leukemias. Adv Pharmacol 2004; 51: 127–167.

41. 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.

42. O’Brien SM, Kantarjian H, Thomas DA, et al. Rituximab doseescalation trial in chronic lymphocytic leukemia. J Clin Oncol 2001; 19: 2165–2170.

43. 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.

44. Schultz H, Klein SK, Rehwald U, et al. Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. Blood 2002; 100: 3115–3120.

45. Savage DG, Cohen NS, Hesdorffer CS, et al. Combined fludarabine and rituximab for low grade lymphoma and chronic lymphocytic leukemia. Leuk Lymphoma 2003; 44: 477–481.

46. 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

47. 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.

48. 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.

49. Byrd JC, Gribben JG, Peterson BL, et al. Select high risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia (CLL): Preliminary justification for risk-adapted therapy. Blood 2004; 104: 476a.

50. Del Principe MI, Del Poeta G, Maurillo L, et al. Addition of rituximab to fludarabine improves progression free survival in untreated ZAP-70 negative chronic lymphocytic leukemia. Blood 2004; 104: 477a.

51. 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: 4079–4088.

52. Casula P, Sorano G, Pulixi D, et al. Oral fludarabine and cyclophosphamide plus rituximab in the treatment of the chronic lymphocytic leukemia. Blood 2005; 106: 5039a.

53. Winkler U, Jensen M, Manzke O, et al. Cytokine-release syndrome in patients with B-cell chronic lymhocytic leukemia and high lymphocyte counts after treatment with anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood 1999; 94: 2217–2224.

54. Byrd JC, Waselenko JK, Maneatis TJ, et al. Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion-related side effects and rapid blood tumor clearance. J Clin Oncol 1999; 17: 791–795.

55. Gupta N, Kavuru S, Patel D, et al. Rituximab-based chemotherapy for steroid-refractory autoimmune hemolytic anemia of chronic lymphocytic leukemia. Leukemia 2002; 16: 2092–2095.

56. Zaja F, Vianelli N, Sperotto A, et al. Anti-CD20 therapy for chronic lymphocytic leukemia - associated autoimmune diseases. Leuk Lymphoma 2003; 44: 1951–1955.

57. Ghazal H. Succesful treatment of pure red cell aplasia with rituximab in patients with chronic lymphocytic leukemia. Blood 2002; 99: 1092–1094.

58. Faderl S, Thomas AD, O’Brien SM, et al. Experience with alemtuzumab plus rituximab in patients with relapsed and refractory lymphoid malignancies. Blood 2003; 101: 3413–3415.