International Journal of Hematology

, Volume 85, Issue 1, pp 59–69

A Multicenter Randomized, Double-Blind, Placebo-Controlled Late-Phase II/III Study of Recombinant Human Interleukin 11 in Acute Myelogenous Leukemia

  • Kensuke Usuki
  • Akio Urabe
  • Yasuo Ikeda
  • Yasuo Ohashi
  • Hideaki Mizoguchi
  • Fumimaro Takaku


To investigate the efficacy of using recombinant human interleukin 11 (rhIL-11) to reduce the need for platelet transfusions, we performed a randomized, double-blind phase II/III study with 110 acute myelogenous leukemia (AML) patients in the first complete remission. Following chemotherapy patients were subcutaneously administered either placebo (n = 37) or rhIL-11 at a dose of 25 μg/kg (n = 37) or 50 μg/kg (n = 36). rhIL-11 administration was well tolerated. There was no difference between the rhIL-11 and placebo groups in the frequency and volume of platelet transfusions. In a perprotocol analysis set (101 patients), the platelet transfusion frequency in the 50-μg/kg group (3.0 ± 1.76 times) was significantly lower than in the placebo group (3.9 ±2.35 times; multiplicity-adjusted P = .049). We analyzed infection-related events retrospectively. The frequency of fever was significantly decreased in the 50-μg/kg, 25-μg/kg, and placebo groups (66.7%, 70.3%, and 89.2%, respectively; P = .018, Cochran-Armitage test). Stomatitis was less frequent in the 50-μg/kg and 25-μg/kg groups (2.8% and 0%, respectively) than in the placebo group (21.6%, P = .0012). These results show that rhIL-11 does not reduce the platelet transfusion requirement in AML patients, but the retrospective analysis confirms the previous finding that rhIL-11 reduces infection in patients undergoing chemotherapy.

Key words

AML IL-11 Platelet Thrombopoiesis Stomatitis Transfusion 


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Copyright information

© The Japanese Society of Hematology 2007

Authors and Affiliations

  • Kensuke Usuki
    • 1
  • Akio Urabe
    • 1
  • Yasuo Ikeda
    • 2
  • Yasuo Ohashi
    • 3
  • Hideaki Mizoguchi
    • 4
  • Fumimaro Takaku
    • 5
  1. 1.Division of HematologyNTT Kanto Medical CenterTokyoJapan
  2. 2.Department of HematologyKeio UniversityTokyoJapan
  3. 3.Department of Biostatistics, Epidemiology, and Preventive Health ScienceUniversity of TokyoTokyoJapan
  4. 4.Tokyo Women’s Medical UniversityTokyoJapan
  5. 5.Jichi Medical SchoolTochigiJapan

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