Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Anaemia and functional iron deficiency are common conditions in patients with lymphoid
malignancies, conditions which reduce significantly the quality of life and increase
morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been
used, but recently their use has been shown to have a negative impact on overall survival in
different oncology populations. Recently published data suggest that intravenous (IV) iron
can be effective in anaemia treatment, even without ESAs. This exploratory study is the first
clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the
data generated may be used for further evaluations of the drug in larger populations. In this
study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours
before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of
FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies,
undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of
FCM, and the effect of FCM treatment on iron status variables in subjects suffering from
lymphoid malignancies.