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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
Author(s) -
Österborg Anders,
Steegmann Juan Luis,
Hellmann Andrzej,
Couban Stephen,
Mayer Jiri,
Eid Joseph E.
Publication year - 2007
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2007.06494.x
Subject(s) - medicine , gastroenterology , lymphoma , chemotherapy , population , anemia , erythropoietin , surgery , environmental health
Summary Anaemia 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 μ g/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 μ g/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.