A randomised controlled parallel group open-label study to evaluate theefficacy and safety of intravenous ferric carboxymaltose versus no treatment inanaemic subjects with lymphoid malignancies and functional iron deficiencyreceiving chemotherapy - FER-FID-CHEMO

• Conditions: Anaemic subjects with lymphoid malignancies and functional iron deficiencyreceiving chemotherapy; MedDRA version: 12.1Level: LLTClassification code 10025631Term: Malignant lymphoid neoplasm NOS; MedDRA version: 12.1Level: LLTClassification code 10022970Term: Iron deficiency; MedDRA version: 12.1Level: LLTClassification code 10002034Term: Anaemia

• Registration Number: EUCTR2009-015767-14-SE
• Lead Sponsor: Vifor (International) AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-26
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subjects (male or female) aged =18, suffering from indolent non-Hodgkin’s
lymphoma, multiple myeloma or chronic lymphocytic leukaemia on any
chemotherapy excluding anthracycline containing.

2. Life expectancy at least 6 months.

3. Received at least 12 weeks (or 3 cycles) of treatment in the current course
of chemotherapy before start of iron therapy.

4. 8.5 g/dL =Hb =10.5 g/dL at time of randomisation.

5. Iron-restricted erythropoiesis as defined:
• Stainable iron in bone marrow combined with transferrin saturation
(TSAT) =20%
OR
• where the evaluation of stainable iron in bone marrow is not possible
or available:
- ferritin >30 ng/mL (women) or >40 ng/mL (men) and
- TSAT =20%

6. Signed informed consent (before any study procedure).

7. Females of child-bearing potential must have a negative urine pregnancy
test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any anaemia treatment within 4 weeks before inclusion (including red
blood cell transfusion, ESA treatment and any oral/parenteral iron
supplementation).

2. Subjects weighing <35 kg.

3. Subjects with increase in Hb during the chemotherapy (>1 g/dL rise
between initiation of CT and screening laboratory value).

4. Folate deficiency (serum folate <4.5 nmol/L) and/or vitamin B12
deficiency (serum cobalamin <145 pmol/L).

5. Ongoing haemolysis defined as serum haptoglobin <0.2 g/L.

6. Recent significant bleeding/surgery.

7. Monotherapy with immunotherapy agents.

8. Known chronic renal failure, creatinine >125 µmol/L.

9. Anthracycline containing chemotherapy regimens.

10. Clinically relevant active inflammatory disease other than the malignant
disease (according to the judgement of the Investigator).

11. Clinically relevant ongoing infectious disease including known human
immunodeficiency virus.

12. Serum-ferritin >800 ng/mL.

13. Ongoing significant neurological or psychiatric disorders including
psychotic disorders or dementia.

14. Significant cardiovascular disease prior to study inclusion including
myocardial infarction within 12 months prior to study inclusion,
congestive heart failure New York Heart Association (NYHA) Grade III
or IV, or poorly controlled hypertension according to the judgment of the
Investigator.

15. Elevation of liver enzymes (aspartate aminotransferase, alanine
aminotransferase) over 3 times above the normal range or known acute
hepatic disorder.

16. Subject currently is enrolled in or has not yet completed at least 30 days
since ending other investigational device or drug study(ies), or subject is
receiving other investigational agent(s).

17. Females who are evidently pregnant (e.g., positive HCG test) or are breast
feeding.

18. Subject is not using adequate contraceptive precautions. Adequate
contraceptive precautions are defined as those which result in a low failure
rate (i.e., less than 1% per year) when used consistently and correctly such
as implants, injectables, combined oral contraceptives, some intra-uterine
devices, sexual abstinence or vasectomised partner. Non-childbearing
potential includes being surgically sterilised at least 6 months prior to the
study or post-menopausal, defined as amenorrhea for at least 12 months.

19. Subject has known sensitivity to any of the products to be administered
during dosing.

20. Subject will not be available for follow-up assessment.

21. Subject has any kind of disorder that compromises the ability of the
subject to give written informed consent and/or to comply with study
procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of efficacy of Ferric carboxymaltose (FCM) given without erythropoiesis stimulating agents (ESA) in the correction of haemoglobin (Hb) levels in anaemic<br>subjects with lymphoproliferative disorder (LPD), undergoing<br>chemotherapy.;Secondary Objective: • Describe safety and tolerability of FCM.<br>• Describe the effect of treatment with FCM on iron status variables in LPD<br>subjects.;Primary end point(s): Mean change in Hb from baseline to Weeks 4, 6 and 8 (end of treatment)<br>in the absence of any red cell transfusion or ESA treatment.