Prospective, multicenter, randomized phase 3 trial of high dose IV iron in combination of erythrocytosis stimulating agents in chemotherapy induced anemia with functional iron deficiency

Hallym University Medical Center0 个研究点目标入组 312 人开始时间: 待定最近更新: 2022年11月28日

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•? Patient who has signed a written consent
•? Age = 19
•? Histologically diagnosed advanced/metastatic solid cancer
•? Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study
•? Anemia with functional iron deficiency
•1) Hemoglobin <10g/dL
•2) functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL
•? ECOG performance status 0-2
•? life expectancy = 24weeks

•? Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin =800 ng/mL OR transferrin saturation =50%)
•? If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)
•? Ongoing bleeding at the time of study registration
•? Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)
•? Presence of bone marrow tumor invasion
•? Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration
•? History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration
•? Past or family history of hemochromatosis
•? History of hypersensitivity to iron treatment or erythropoiesis stimulating agents
•? Uncontrolled acute or chronic infection
•? Renal dysfunction (serum creatinine =2.0 mg/dL, or glomerular filtration rate <30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal)
•? Pregnant or lactating women

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