A comparative study of low molecular weight IV iron dextran (CosmoFer®) versus per os iron for the treatment of anaemia in patients with haematological malignancies receiving epoietin treatment

Hospital Errikos Dunant- Department of Hematology0 个研究点目标入组 110 人开始时间: 2008年1月10日最近更新: 2012年3月19日

适应症

试验速览

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•Patients with newly diagnosed CLL, lymphoma (both Hodgkin’s and Non Hodgkin’s lymphoma) or MDS (RA, RAS, RAEB, and CMML) with a need for Fe due to anaemia and ESA treatment
•Age = 18 years at screening
•Hb = 11 g/dL
•Serum Ferritin < 800 µgram/l
•TSAT < 30 %
•ECOG PS 0-2
•Life expectancy beyond 12 months
•Willingness to participate after written informed consent
•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

•Non-Fe deficiency anaemia (Vitamin B12 deficiency, folic acid deficiency, gastrointestinal bleeding, or hemolysis)
•Fe overload or disturbances in utilisation of Fe (e.g. haemochromatosis and haemosiderosis)
•Previous hypersensitivity to Fe Dextran or Fe mono- or disaccharide complexes
•Patients with a history of asthma, eczema, or other atopic allergies
•Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal)
•Acute or chronic infections (evaluated by clinical judgement derived by WBC and CRP if deemed necessary by investigator)
•Rheumatoid arthritis with symptoms or signs of active inflammation
•Pregnancy or nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
•Planned elective surgery during the study where significant blood loss is expected
•Participation in any other clinical trial within three months prior to screening
•Uncontrolled hypertension (> 140/90 mmHg) despite optimal therapy
•Known epilepsy
•Renal dysfunction (serum creatinine > 2.0 mg/dl)
•Prior RBC transfusion within the past two weeks
•Prior Fe dextran treatment within the past four weeks
•Prior EPO treatment within the past four weeks

发起方

Hospital Errikos Dunant- Department of Hematology