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

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Abstract

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.

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Authors and Affiliations

  1. Division of Hematology, NTT Kanto Medical Center, 5-9-22 Higashi-Gotanda, Shinagawa-ku, 141-8625, Tokyo, Japan

    Kensuke Usuki & Akio Urabe

  2. Department of Hematology, Keio University, Tokyo, Japan

    Yasuo Ikeda

  3. Department of Biostatistics, Epidemiology, and Preventive Health Science, University of Tokyo, Tokyo, Japan

    Yasuo Ohashi

  4. Tokyo Women’s Medical University, Tokyo, Japan

    Hideaki Mizoguchi

  5. Jichi Medical School, Tochigi, Japan

    Fumimaro Takaku

Authors
  1. Kensuke Usuki
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  2. Akio Urabe
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  3. Yasuo Ikeda
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  4. Yasuo Ohashi
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  5. Hideaki Mizoguchi
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  6. Fumimaro Takaku
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Correspondence to Kensuke Usuki.

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Usuki, K., Urabe, A., Ikeda, Y. et al. A Multicenter Randomized, Double-Blind, Placebo-Controlled Late-Phase II/III Study of Recombinant Human Interleukin 11 in Acute Myelogenous Leukemia. Int J Hematol 85, 59–69 (2007). https://doi.org/10.1532/IJH97.06027

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