NCT05768997招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Mean Hb change
研究概览
简要总结
This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who has signed a written consent
- •Age ≥ 19 ③ 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
- •Hemoglobin <10g/dL
- •functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks
排除标准
- •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 ⑨ History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ⑩ Uncontrolled acute or chronic infection ⑪ 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) ⑫ Pregnant or lactating women
研究组 & 干预措施
High dose IV iron plus ESA combination arm
Experimental
干预措施: Ferric Derisomaltose Injection (Drug)
High dose IV iron plus ESA combination arm
Experimental
干预措施: Darbepoetin Alfa Injection (Drug)
ESA monotherapy arm
Active Comparator
干预措施: Darbepoetin Alfa Injection (Drug)
结局指标
主要结局
Mean Hb change
时间窗: from baseline to 12 weeks
Mean change in Hb concentration from baseline to 12 weeks
次要结局
- Time to hemoglobin response(during 12-week study period)
- Proportion of patients requiring RBC transfusion during 12-week study period(during 12-week study period)
- Safety analysis(during 12-week study period)
- Hemoglobin response(during 12-week study period)
- Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L(during 12-week study period)
研究者
Zang, Dae Young
Principal Investigator
Hallym University Medical Center
研究点 (1)
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