Phase II study of three dose levels of continuous erythropoietin receptor activator (C.E.R.A.) in anaemic patients with aggressive non-Hodgkin's lymphoma receiving combination chemotherapy

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SummaryAnaemia is a common complication in the treatment of patients with aggressive non-Hodgkin lymphoma (NHL), but there are no published data on the effect of erythropoiesis-stimulating agents in such patients. This is the first open-label, phase II, dose-finding study to evaluate the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.). Ninety-three anaemic patients with aggressive NHL who were receiving chemotherapy (including many advanced NHL, heavily pretreated patients) were randomised to receive 2·1, 4·2 or 6·3 μg/kg C.E.R.A. subcutaneously once every 3 weeks for 12 weeks. Haematopoietic response was achieved in 45%, 57% and 65% of patients at the respective dose level. During weeks 5–13, the mean haemoglobin changes from baseline in the intent-to-treat population were increases of 0·2, 2·4, and 5·7 g/l in the 2·1, 4·2, and 6·3 μg/kg treatment groups, respectively, and 4·4, 5·7 and 6·8 g/l in the per-protocol population at the respective dose levels. C.E.R.A. was generally well tolerated in all three groups. C.E.R.A. appeared to have dose-dependent clinical activity in most anaemic patients with aggressive NHL who were receiving chemotherapy.

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