EUCTR2008-006268-12-DE进行中（未招募）不适用
Early treatment with deferasirox (Exjade®) in low risk MDS - Exjade-Early-Trial
Friedrich-Alexander-Universitaet Erlangen-Nuernberg0 个研究点开始时间: 2009年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-MDS of subtype RA, RARS, RCMD, RCMD-RS (i.e. lower risk)
- •-RAEB I allowed, if clinically stable for > 3 months
- •-5q-minus syndrome allowed, if lenalidomide unsuccessful or unavailable at the time
- •of inclusion
- •-IPSS score < intermediate-1
- •-transfusion dependent or Hb < 10,5 g/dl
- •-History of less than 20 units of red blood cell transfusions or 100mL/kg of
- •prepacked red blood cells (PRBCs), except for tranfusions for acute bleeding
- •-Serum ferritin > 300 µg/l and < 1500 µg/l. This level should have been verified at
- •least at two occasions within 3 months. Samples must be obtained in the absence
- •of concomitant severe infection
- •-no indication for EPO (due to high endogenous EPO levels) or EPO without benefit
- •in the past
- •-no indication and/or no plans for cytostatic drugs
- •-no previous exposure to cytostatic drugs, thalidomide, lenalidomide, G-CSF or EPO
- •or exposure to any of these drugs has been terminated since > 8 weeks (4 weeks
- •for G-CSF).
- •-no indication and/or no plans for stem cell transplantation
- •-stable or worsening cytopenia during the past 8 weeks. If in doubt, extend
- •screening period to > 8 weeks
- •-Patients of either gender and age > 18 years
- •-Life expectancy > 12 months
- •-Females of childbearing potential must use double-barrier contraception.
- •-Written informed consent by the patient
- •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
排除标准
- •-Treatment with deferasirox or other chelation therapy for periods > 4 weeks before
- •study start
- •-Patients with a concomitant second malignant disease, possibly interfering with life
- •-Patients with mean levels of alanine aminotransferase (ALT) > 5x ULN
- •-Patients with uncontrolled systemic hypertension
- •-Patients with serum creatinine > 1.5x the upper limit of normal (ULN) or a creatinine
- •clearance < 60 ml/min according to the MDRD formula (Levey 2005)
- •-History of nephrotic syndrome
- •-Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
- •-Patients with psychiatric or addictive disorders which prevent them from giving their
- •informed consent or undergoing study treatment
- •-Patients treated with systemic investigational drugs within the past 4 weeks or
- •topical investigational drug within the past 7 days
- •-Any other surgical or medical condition which might significantly alter the
- •absorption, distribution, metabolism or excretion of any drug. The investigator
- •should be guided by evidence of any of the following:
- •*history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or
- •rectal bleeding;
- •*history of major gastrointestinal tract surgery such as gastrectomy,
- •gastroenterostomy, or bowel resection;
- •*history of pancreatic injury or pancreatitis; indications of impaired pancreatic
- •function/injury as indicated by abnormal lipase or amylase;
- •*history of urinary obstruction or difficulty in voiding
- •-History of non-compliance to medical regimens and patients who are considered
- •potentially unreliable and/or not cooperative
- •-History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
- •such abuse as indicated by the laboratory assays conducted during the run-in period
- •-Patients with active uncontrolled infectious disease
- •-Pregnancy or breast feeding
- •-QT > 470 msec on screening ECG
- •-Patients with a history of Torsades de Pointes
研究者
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