Spots Global Cancer Trial Database for Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

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Trial Identification

Brief Title: Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

Official Title: Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy

Study ID: NCT01101399

Conditions

Iron-Deficiency Anemia

Interventions

Ferric carboxymaltose

Study Description

Brief 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.

Detailed Description: Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of FCM in the treatment of anaemia in LPD subjects with functional iron deficiency (FID), undergoing chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion to receive intravenous (IV) infusions of FCM or no FCM infusions (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). After randomisation, the visits are scheduled weekly until Week 8.