EUCTR2009-012418-38-BE进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO) - TELESTO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
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
- •Male or female , =18 years of age, with low or intermediate (int-1) risk MDS, as determined by IPSS score. This must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable.
- •Weight between 35-135 kg
- •Ferritin > 1000 mcg/L at screening
- •History of transfusion of 15 to 75 pRBC units
- •Chelation-naïve patients
- •Anticipated to be transfused with at least 8 units of pRBC annually during the study
- •Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation
- •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 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •More than 6 months of cumulative iron chelation therapy (such as daily deferasirox or deferiprone or 5x/week deferoxamine)
- •More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a
- •3 month period)
- •Creatinine Clearance <40 ml/min
- •Serum creatinine > 1.5xULN at screening
- •Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at Visit 1 or Visit 2 (or alternatively in two of three samples obtained for screening)
- •ECOG performance status > 2
- •Left ventricular ejection fraction < 50% by echocardiography
- •A history of hospitalization for congestive heart failure
- •Systemic diseases which would prevent study treatment (e.g.uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
- •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)
- •History of HIV positive test result (ELISA or Western blot)
- •Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start
- •ALT or AST > 3.5 × ULN at screening
- •Total bilirubin > 1.5 x ULN at screening
- •Diagnosis of liver cirrhosis
- •Patients participating in another clinical trial other than an observational registry study
- •Patients with a history of another malignancy within the past five years, with the exception of basal skin carcinoma or cervical carcinoma in situ
- •History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative
- •Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
- •Pregnant, intending-to-become pregnant, or breast-feeding patients
- •History of drug or alcohol abuse within the 12 months prior to enrollment
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