The Fludara® (fludarabine phosphate) For Injection bibliography is a listing of publications referenced in the product monograph. For a more comprehensive listing, visit the National Library of Medicine's PubMed Advanced MEDLINE Search web site.

Please see full prescribing information for Fludara.

 

  1. Foon KA, Rai KR, Gale RP. Chronic lymphocytic leukemia: new insights into biology and therapy. Ann Intern Med. 1990; 113:525-39.
  2. Cancer Statistics Review, 1983-1987. Bethesda, MD: National Cancer Institute, Division of Cancer Prevention and Control Surveillance Program, NIH publication 90-2789.
  3. Conley CL, Misiti J, Laster AJ. Genetic factors predisposing to chronic lymphocytic leukemia and to autoimmune disease. Medicine. 1980; 59:323-334.
  4. Freeman AS, Boyd AW, Bieber FR, et al. Normal cellular counterparts of B cell chronic lymphocytic leukemia. Blood. 1987; 70:418-427.
  5. Gadol N, Ault KA. Phenotypic and functional characterization of human LEU1 (CD5) B cells. Immunol Rev. 1986; 93:23-34
  6. Hardy RR, Hayakawa K. Development and physiology of LY-1 B and its human homolog LEU-1 B. Immunol Rev. 1986; 93: 53-79.
  7. Guilbert B, Dighiero G, Avrameas S. Naturally occurring antibodies against nine common antigens in human sera. I. Detection, isolation, and characterization. J Immunol. 1982; 128:2779-2787.
  8. Sthoeger ZM, Wakai M, Tse DB, et al. Production of autoantibodies by CD5-expressing B lymphocytes from patients with chronic lymphocytic leukemia. J Exp Med. 19889; 169:255-268.
  9. Borche L, Lim A, Binet JL, et al. Evidence that chronic lymphocytic leukemia B lymphocytes are frequently committed to production of natural autoantibodies. Blood. 1990; 76:562-569.
  10. Kipps TJ, Fong S, Tomhave E, et al. High-frequency expression of a conserved K light-chain variable-region gene in chronic lymphocytic leukemia. Proc Natl Acad Sci USA. 1987; 84:2916-2920.
  11. Kipps TJ, Tomhave E, Chen PP, et al. Autoantibody-associated k light chain variable region gene expressed in chronic lymphocytic leukemia with little or no somatic mutation: implications for etiology and immunotherapy. J Exp Med. 1988; 167:840-852.
  12. Kay NE, Burton J, Wagner D, et al. The malignant B cells from B-chronic lymphocytic leukemia patients release TAC-soluble interleukin-2 receptors. Blood. 1988; 72:447-450.
  13. Knuutila S, Elonen E, Teerenhovi L, et al. Trisomy 12 in B cells of patients with B-cell chronic lymphocytic leukemia. N Engl J Med. 1986; 314:865-869.
  14. Juliusson G, Oscier DG, Fitchett M, et al. Prognostic subgroups in B-cell chronic lymphocytic leukemia: defined by specific chromosomal abnormalities. N Engl J Med. 1990; 323:720-724.
  15. Juliusson G, Friberg K, Gahrton G. Consistency of chromosomal aberrations in chronic B-lymphocytic leukemia: a longitudinal cytogenetic study of 41 patients. Cancer. 1988; 33:155-160.
  16. Nowell PC, Moreau L. Growney P, et al. Karyotypic stability in chronic B-cell leukemia. Cancer Genet Cytogenet. 1988; 33:155-160.
  17. Juliusson G, Gahrton G. Chromosomal aberrations in B-cell chronic lymphocytic leukemia: pathogenetic and clinical implications. Cancer Genet Cytogenet. 1990; 45:143-160.
  18. Chapel HM, Bunch C. Mechanisms of infection in chronic lymphocytic leukemia. Semin Hematol. 1987; 24:291-296.
  19. Cone L, Uhr JW. Immunologic deficiency disorders associated with chronic lymphocytic leukemia and multiple myeloma. J Clin Invest. 1964; 43:2241-2248.
  20. Kay NE, Perri RT. Evidence that large granular lymphocytes from B-CLL patients with hypogammaglobulinemia down-regulate B-cell immunoglobulin synthesis. Blood. 1989; 73:1016-1019.
  21. Kay NE. Abnormal T-cell subpopulation function in CLL: excessive suppressor (Tg) and deficient helper (Tm) activity with respect to B-cell proliferation. Blood. 1981; 57:418-420.
  22. Platsoucas CD, Fernandes G, Gupta SL, et al. Defective spontaneous and antibody-dependent cytotoxicity mediated by E-rosette-positive and E-rosette-negative cells in untreated patients with chronic lymphocytic leukemia: augmentation by in vitro treatment with interferon. J Immunol. 1980; 125:1216-1223.
  23. Kay NE, Kaplan ME. Defective T cell responsiveness in chronic lymphocytic leukemia: analysis of activation events. Blood. 1986; 67:578-581.
  24. Hokland P, Ellegaard J. Immunological studies in chronic lymphocytic leukemia–II. Natural killer- and antibody-dependent cellular cytotoxicity potentials of malignant and non-malignant lymphocyte subsets and the effect of a-interferon. Leuk Res. 1981: 5:349-355.
  25. Kay NE, Zarling J. Restoration of impaired natural killer cell activity of B-chronic lymphocytic leukemia patients by recombinant interleukin-2. Am J Hematol. 1987; 24:161-167.
  26. Burton JD, Weitz CH, Kay NE. Malignant chronic lymphocytic leukemia B cells elaborate soluble factors that down-regulate T cell and NK function. Am J Hematol. 1989; 30: 61-67.
  27. Rai KR, Sawitsky A, Cronkite EP, et al. Clinical staging of chronic lymphocytic leukemia. Blood. 1975; 46:219-234.
  28. Rai KR. A critical analysis of staging in CLL. In: Chronic Lymphocytic Leukemia: Recent Progress and Future Direction. Gale RP, Rai KR, eds. New York, NY: Alan R. Liss, Inc.; 1987:253-264.
  29. Trump DL, Mann RB, Phelps R, et al. Richter's syndrome: diffuse histiocytic lymphoma in patients with chronic lymphocytic leukemia: a report of five cases and review of the literature. Am J Med. 1980; 68:539-548.
  30. Melo JV, Catovsky D, Gregory WM, et al. The relationship between chronic lymphocytic leukaemia and prolymphocytic leukaemia. IV. Analysis of survival and prognostic features. Br J Haematol. 1987; 65:23-29.
  31. Binet JL, Auquier A, Dighiero G, et al. A new prognostic classification of chronic lymphocytic leukemia derived from a multivariate survival analysis. Cancer. 1981; 48:198-206.
  32. Cheson BD, Bennett JM, Rai KR. Guidelines for clinical protocols for chronic lymphocytic leukemia: recommendations of the National Cancer Institute-sponsored working group. Am J Hematol. 1988; 29:152-163.
  33. Cheson BD. Current approaches to the chemotherapy of B-cell chronic lymphocytic leukemia: a review. Am J Hematol. 1989 ; 32:72-77.
  34. Montserrat E, Sanchez-Bisono J, Vinolas N, et al. Lymphocyte doubling time in chronic lymphocytic leukaemia: analysis of its prognostic significance. Br J Haemotol. 1986; 62:567-575.
  35. Rozman C, Montserrat E, Rodríguez-Fernández JM, et al. Bone marrow histologic pattern–The best single prognostic parameter in chronic lymphocytic leukemia: a multivariate survival analysis of 329 cases. Blood. 1984; 64:642-648.
  36. Montserrat E, Rozman C. Clinicopathologic staging of chronic lymphocytic leukemia. In: Chronic Lymphocytic Leukemia: Recent Progress and Future Direction. Gale RP, Rai KR, eds. New York, NY: Alan R. Liss, Inc.; 1987:215-224.
  37. Han T, Rai, KR. Management of chronic lymphocytic leukemia. Hematol Oncol Clin North Am. 1990; 4:431-445.
  38. Knospe WH, Loeb V Jr, Huguley CM Jr. Bi-weekly chlorambucil treatment of chronic lymphocytic leukemia. Cancer. 1974; 33:555-562.
  39. Han T, Ezdinli EZ, Shimaoka K, et al. Chlorambucil vs combined chlorambucil-corticosteroid therapy in chronic lymphocytic leukemia. Cancer. 1973; 31:502-508.
  40. French Cooperative Group on Chronic Lymphocytic Leukemia. A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. Blood. 1990; 75:1422-1425.
  41. Hansen MM, Anderson E, Christensen BE, et al. CHOP versus prednisolone + chlorambucil in chronic lymphocytic leukemia (CLL): preliminary results of a randomized multicenter study. Nouv Rev Fr Hematol. 1988; 30:433-436.
  42. French Cooperative Group on Chronic Lymphocytic Leukemia. CHOP regimen versus intermittent chlorambucil-prednisone in stage B chronic lymphocytic leukemia: short term results from a randomized clinical trial. Nouv Rev Fr Hematol. 1988; 30:499-452.
  43. Dillman RO, Mick R, McIntyre OR. Pentostatin in chronic lymphocytic leukemia: a phase II trial of Cancer and Leukemia Group B. J Clin Oncol. 1989; 7:433-438.
  44. Grever MR, Kopecky KJ, Coltman CA, et al. Fludarabine monophosphate: a potentially useful agent in chronic lymphocytic leukemia. Nouv Rev Fr Hematol. 1988; 30:457-459.
  45. Keating MJ, Kantarjian H, Talpaz M, et al. Fludarabine: a new agent with major activity against chronic lymphocytic leukemia. Blood. 1989; 74:19-25.
  46. Piro LD, Carrera CJ, Beutler E, et al. 2-Chlorodeoxyadenosine: an effective new agent for the treatment of chronic lymphocytic leukemia. Blood. 1988; 72:1069-1073.
  47. Montgomery JA, Hewson K. Nucleosides of 2-fluoroadenine. J Med Chem. 1969; 12:498-504.
  48. Brockman RW, Schabel FM Jr, Montgomery JA. Biologic activity of 9-beta-D-arabinofuranosyl-2-fluoroadenine, a metabolically stable analog of 9-beta-D-arabinofuranosyladenine. Biochem Pharmacol. 1977; 26:2193-2196.
  49. Brockman RW, Cheng Y-C, Schabel FM Jr, et al. Metabolism and chemotherapeutic activity of activity of 9-beta-D-arabinofuranosyl-2-fluoroadenine against murine leukemia L1210 and evidence for its phosphorylation by deoxycytidine kinase. Cancer Res. 1980; 40:3610-3615.
  50. Dow LW, Bell DE, Poulakos L, et al. Differences in metabolism and cytotoxicity between 9-beta-D- arabinofuranosyladenine and 9-beta-D-arabinofuranosyl-2-fluoroadenine in human leukemic lymphoblasts. Cancer Res. 1980; 40:1405-1410
  51. White EL, Shaddix SC, Brockman RW, et al. Comparison of the actions of 9-beta-D-arabinofuranosyl-2-fluoroadenine and 9-beta-D-arabinofuranosyladenine on target enzymes from mouse tumor cells. Cancer Res. 1982; 42:2260-2264.
  52. Catapano CV, Chandler KB, Fernandes DJ. Effects of anticancer agents on primer RNA formation in human leukemia cells. Proc Am Assoc Cancer Res. 1990; 31:420. Abstract.
  53. Spriggs D, Robbins G, Mitchell T, et al. Incorporation of 9-beta-D-arabinofuranosyl-2-fluoroadenine into HL-60 cellular RNA and DNA. Biochem Pharmacol. 1986; 35:247-252.
  54. Plunkett W, Huang P, Gandhi V. Metabolism and action of fludarabine phosphate. Semin Oncol. 1990; 17(Suppl 8):3-17.
  55. Avramis VI, Plunkett W. Metabolism of 9-beta-D-arabinosyl-2-fluoroadenine-5'-phosphate by mice bearing P388 leukemia. Cancer Drug Deliv. 1983;1:1-10.
  56. Avramis VI. Pharmacodynamics and proposed mechanism of therapeutic action and host toxicity of 9-beta-D-arabinofuranosyl-2-fluoroadenine monophosphate (F-araAMP) in P388 murine leukemia-bearing mice. Cancer Invest. 1989; 7:129-137.
  57. Barrueco JR, Jacobsen DM, Chang C-H, et al. Proposed mechanism of therapeutic selectivity for 9-beta-D-arabinofuranosyl-2-fluoroadenine against murine leukemia based upon lower capacities for transport and phosphorylation in proliferative intestinal epithelium compared to tumor cells. Cancer Res. 1987; 47:700-706.
  58. Mitchell BS, Kelley WN. Purinogenic immuno-deficiency diseases: clinical features and molecular mechanisms. Ann Intern Med. 1980; 92:826-831.
  59. Grever MR, Siaw MFE, Jacob WF, et al. The biochemical and clinical consequences of 2'-deoxycoformycin in refractory lymphoproliferative malignancy. Blood. 1981; 57:406-417.
  60. Boldt DH, Von Hoff DD, Kuhn JG, et al. Effects on human peripheral lymphocytes of in vivo administration of 9-beta-D-arabinofuranosyl-2-fluoroadenine-5'-monophosphate (NSC 312887), a new purine antimetabolite. Cancer Res. 1984; 44:4661-4666.
  61. Leiby JM, Snider KM, Kraut EH, et al. Phase II trial of 9-beta-D-arabinofuranosyl-2-fluoroadenine 5'-monophosphate in non-Hodgkin's lymphoma: prospective comparison of response with deoxycytidine kinase activity. Cancer Res. 1987; 47:2719-2722.
  62. Redman J, Cabanillas F, McLaughlin P, et al. Fludarabine phosphate: a new agent with major activity in low grade lymphoma. Proc Am Assoc Cancer Res. 1988; 29:211. Abstract.
  63. Hochster H, Kim K, Green M, et al. Fludarabine is highly active in refractory low grade lymphoma. Proc Am Soc Clin Oncol. 1989; 8:254. Abstract.
  64. Noker PE, Duncan GF, El Dareer SM, et al. Disposition of 9-beta-D-arabinofuranosyl-2-fluoroadenine 5'-phosphate in mice and dogs. Cancer Treat Rep. 1983; 67:445-456.
  65. Hersh MR, Kuhn JG, Phillips JL, et al. Pharmacokinetic study of fludarabine phosphate (NSC 312887). Cancer Chemother Pharmacol. 1986; 17:277-280.
  66. Danhauser L, Plunkett W, Keating M, et al. 9-beta-D-arabinofuranosyl-2-fluoroadenine 5'-monophosphate pharmacokinetics in plasma and tumor cells of patients with relapsed leukemia and lymphoma. Cancer Chemother Pharmacol. 1986; 18:145-152.
  67. Danhauser L, Plunkett W, Liliemark J, et al. Comparison between the plasma and intracellular pharmacology of 1-beta-D-arabinofuranosylcytosine and 9-beta-D-arabinofuranosyl-2-fluoroadenine 5'-monophosphate in patients with relapsed leukemia. Leukemia. 1987; 1:638-643.
  68. Malspeis L, Grever MR, Staubus AE, et al. Pharmacokinetics of 2-F-ara-A (9-beta-D-arabinofuranosyl-2-fluoroadenine) in cancer patients during the phase I clinical investigation of fludarabine phosphate. Semin Oncol. 1990; 17(Suppl 8):18-32.
  69. Data on file, Berlex Laboratories.
  70. Sawitsky A, Rai KR, Glidewell O, et al. Comparison of daily versus intermittent chlorambucil and prednisone therapy in the treatment of patients with chronic lymphocytic leukemia. Blood. 1977; 50:1049-1059.
  71. Gandara DR, George CB, Ries CA, et al. Treatment of refractory chronic lymphocytic leukemia with prednimustine: a phase II study using strict response criteria. Cancer Chemother Pharmacol. 1987; 19:165-168.
  72. Grever MR, Leiby JM, Kraut EH, et al. Low-dose deoxycoformycin in lymphoid malignancy. J Clin Oncol. 1985; 3:1196-1201.
  73. Montserrat E, Alcala A, Parody R, et al. Treatment of chronic lymphocytic leukemia in advanced stages. A randomized trial comparing chlorambucil plus prednisone versus cyclophosphamide, vincristine and prednisone. Cancer. 1985; 56:2369-2375.
  74. Oken ME, Kaplan ME. Combination chemotherapy with cyclophosphamide, vincristine, and prednisone in the treatment of refractory chronic lymphocytic leukemia. Cancer Treat Rep. 1979; 63:441-447.
  75. Kempin S, Lee BJ, Thaler HT, et al. Combination chemotherapy of advanced chronic lymphocytic leukemia: the M-2 protocol (vincristine, BCNU, cyclophosphamide, melphalan, and prednisone). Blood. 1982; 60:1110-1121.
  76. Keating MJ, Scouros M, Murphy S, et al. Multiple agent chemotherapy (POACH) in previously treated and untreated patients with chronic lymphocytic leukemia. Leukemia. 1988; 2:157-164.
  77. Bunch C. Management of infection in chronic lymphocytic leukemia. In: Chronic Lymphocytic Leukemia: Recent Progress and Future Direction. Gale RP, Rai KR, eds. New York, NY: Alan R. Liss, Inc.; 1987:373-381.
  78. Hurst PG, Habib MP, Garewal H, et al. Pulmonary toxicity associated with fludarabine monophosphate. Invest New Drugs. 1987; 5:207-210.
  79. Cooper JAD, White DA, Matthay RA. Drug-induced pulmonary disease. Part I: Cytotoxic drugs. Am Rev Respir Dis. 19886; 133:321-340.
  80. Warrell RP Jr, Berman E. Phase I and II study of fludarabine phosphate in leukemia: therapeutic efficacy with delayed central nervous system toxicity. J Clin Oncol. 1986; 4:74-79.
  81. Spriggs DR, Stopa E, Mayer RJ, et al. Fludarabine phosphate (NSC 312878) infusions for the treatment of acute leukemia: phase I and neuropathological study. Cancer Res. 1986; 46:5953-5958.
  82. Merkel DE, Griffin NL, Kagen-Hallet K, et al. Central nervous system toxicity with fludarabine. Cancer Treat Rep. 1986; 70:1449-1450.
  83. Chun HG, Leyland-Jones BR, Caryk SM, et al. Central nervous system toxicity of fludarabine phosphate. Cancer Treat Rep. 1986; 70:1225-1228.
  84. List AF, Kummet TD, Adams JD, et al. Tumor lysis syndrome complicating treatment of chronic lymphocytic leukemia with fludarabine phosphate. Am J Med. 1990; 89:388-390.
  85. Rubenstein DB, Longo DL. Peripheral destruction of platelets in chronic lymphocytic leukemia: recognition, prognosis and therapeutic implications. Am J Med. 1981; 71:729-732.
  86. Miller DG, Karnofsky DA. Immunologic factors and resistance to infection in chronic lymphocytic leukemia. Am J Med. 1961; 31:748-757.
  87. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. N Engl J Med. 1988; 319:902-907.

WARNING: FLUDARA FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. FLUDARA FOR INJECTION can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, FLUDARA FOR INJECTION was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity has been rarely (less than or equal to 0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported to occur after one or more cycles of treatment with FLUDARA FOR INJECTION. Patients undergoing treatment with FLUDARA FOR INJECTION should be evaluated and closely monitored for hemolysis.

In a clinical investigation using FLUDARA FOR INJECTION in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of FLUDARA FOR INJECTION in combination with pentostatin is not recommended.

Please see full Prescribing Information for FLUDARA®.

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Manufactured by Ben Venue Laboratories, Bedford, OH 44146