, 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

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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.