Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Number of patients with hematopoietic response at 10 weeks.
研究概览
简要总结
Anemia in patients with cancer is a common problem associated with an impaired quality of life.
Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements.
Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia.
Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency.
In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.
详细描述
- Iron Deficiency and Cancer The literature review therefore presents uncertainties do not allow the routine application of intravenous iron associated with ESAs. The SOR also conclude that IV iron is "consider" if iron deficiency.
These uncertainties are the heterogeneity of the study populations, contradictory results and the use of patterns intravenous iron binding and non-standardized.
The investigators focus in this study in patients with chemotherapy-induced anemia with functional iron deficiency is a cause of lack of response to ESA. Indeed, patients with true iron deficiency seems to justify a routine iron supplementation. In contrast, patients without iron deficiency do not warrant formal way of initiating such treatment (although the literature is contradictory).
This study aims to evaluate, in patients with chemotherapy-induced anemia and functional iron deficiency, the efficacy and safety of the combination epoietin zeta + Iron in concomitant intravenous or sequential.
Because data RCP (Summary of Product Characteristics), ease of use, its safety profile, the ability to achieve higher doses of iron with a lower frequency and with better adherence, the ferric carboxymaltose was chosen as an intravenous iron. One specialty is available, the Ferinject ® (Laboratoires VIFOR Pharma).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient> 18 years;
- •Metastatic or locally advanced non-curable undergoing chemotherapy or lymphoid disease for which chemotherapy is indicated solid cancerous disease;
- •Patient for which there are at least 3 cycles or 3 months of chemotherapy;
- •Haemoglobin between 8.5 and 11 g / dL;
- •Functional martial deficiency defined by a coefficient of transferrin saturation and serum ferritin ≤ 20% between 100 and 800 mg / L;
- •Life expectancy> 3 months;
- •ECOG ≤ 2.
排除标准
- •Documented hemochromatosis ;
- •AST and / or ALT> 2.5N;
- •Renal impairment with Cockcroft clearance <30 mL / min;
- •Vitamin B12 deficiency or folate;
- •Hemolysis;
- •Infectious disease being untreated;
- •Haemorrhagic syndrome related or not with the tumor;
- •Hypersensitivity to Ferinject ® or any of the excipients;
- •Land atopic asthma or eczema known
- •Contraindication to EPO;
- •Taking a supplement to oral iron;
- •Treatment with EPO within 6 months prior to study entry;
- •No transfusion of packed red cells within 15 days before enrollment or randomization in the study;
- •Participation in another clinical trial;
- •Psychiatric pathology can disrupt the course of treatment or prevent the interpretation of results;
- •Pregnant or lactating women;
- •Persons deprived of liberty;
- •Major subject to a measure of legal protection or unable to consent.
研究组 & 干预措施
Iron and I.V. epoietin zeta sequential
干预措施: ARM B: IV iron + epoietin zeta sequence (Drug)
Epoietin zeta
干预措施: ARM C : single epoietin zeta (Drug)
Concomitant iron and I.V. epoietin zeta
干预措施: ARM A : IV iron + epoietin zeta (Drug)
结局指标
主要结局
Number of patients with hematopoietic response at 10 weeks.
时间窗: The rate of hematopoietic response will be evaluated 10 weeks
The primary objective is to evaluate the rate of hematopoietic response to 10 weeks in patients with anemia and functional iron deficiency treated epoietin zeta + carboxymaltose concomitant IV iron, by epoietin zeta + carboxymaltose IV ferric sequential or epoietin zeta alone
次要结局
- Number of transfusion requirements(The number of transfusions will be evaluated weekly Week 1-16)