EUCTR2009-015767-14-DE进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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%
- •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
- •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
排除标准
- •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
- •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.
研究者
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