A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To evaluate the antioxidative effect of Exjade therapy in MDS patients
研究概览
简要总结
Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or low.
- •Patients who already received ≥20 unit (100 mL/kg) of packed red blood cells and showing evidence of iron overload (serum ferritin >1000 µg/L).
- •Patients post stem cells transplantation with disease recurrence with MDS IPSS score low or intermediate
- •Patients who have given consent personally in writing
排除标准
- •Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or High.
- •Patients with serum creatinine >2.0 x ULN
- •Patients with ALT(SGPT) levels > 5 x ULN
- •Significant proteinuria as indicated by a urinary protein/creatinine ratio >0.5 mg/mg in a non-first void urine sample on two assessments during the screening period.
- •History of HIV positive test result. When there are any signs or symptoms indicative of the disease even if the diagnosis is not made, additional test should be conducted.
- •History of clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)
- •Patients with systemic uncontrolled hypertension
- •Patients with unstable cardiac disease not controlled by standard medical therapy
- •Systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
- •Pregnancy or breast feeding. Female of child-bearing potential should conduct contraception during the clinical trial.
- •Patients treated with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
- •Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
- •Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the study protocol
- •History of hypersensitivity to any of the study drug or excipients
研究组 & 干预措施
evaluating the effect of -Exjade
evaluating the effect of -Exjade (Deferasirox)_on oxidative stress parameters of blood cells in patients with Low risk Mylodysplastic syndrome ( MDS) with Iron over load
干预措施: Exjade (Drug)
结局指标
主要结局
To evaluate the antioxidative effect of Exjade therapy in MDS patients
时间窗: one year
with iron over load by evaluating oxidative stress parameters
时间窗: one year
pre and post treatment
时间窗: one year
次要结局
- To evaluate the safety and tolerability of Exjade over the treatment period.(one year)
- To analyze iron overload after Exjade treatment period.(one year)
- To evaluate transfusion requirements.(one year)
- To confirm the value of LPI, LIP, and Hepcidin as a marker for accurate monitoring of chelation therapy in MDS patients with iron over load.(one year)
研究者
eliezer rachmilewitz
Head of Hematology Department , E. Wolfson Medical center ,Holon- Israel.
Wolfson Medical Center