Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy (FID-CHEMO)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in haemoglobin from baseline to Week 4 [ Time Frame: Weeks 4 post baseline ] [ Designated as safety issue: No ]
- The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
- Change in haemoglobin from baseline to Week 6 [ Time Frame: 6 weeks after baseline ] [ Designated as safety issue: No ]
- Change in haemoglobin from baseline to Week 8 [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Ferric carboxymaltose
Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2).
Drug: Ferric carboxymaltose
Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2).
Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
Other Name: Ferinject
No Intervention: Local standard of care.
Subjects will be treated according to the local institutional practice.
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.
|Hamburg, Germany, 20246|
|Department of Medicine, St Görans Hospital (Capio St Görans Sjukhus)|
|Stockholm, Sweden, SE-112 81|
|Principal Investigator:||Torbjörn Karlsson, MD, PhD||Capio St Görans Sjukhus, Stockholm|
|Study Director:||Morgan McNamara||Vifor Pharma, CH-8152 Glattbrugg, Switzerland|