EUCTR2018-003542-17-IT进行中（未招募）1 期
Early and low dose Deferasirox (3.5 mg/kg FCT) to suppress NTBI and LPI as early intervention to prevent tissue iron overload in lower risk MDS - FISM_IRON-MDS
FONDAZIONE ITALIANA SINDROMI MIELODISPLASTICHE ETS0 个研究点目标入组 60 人开始时间: 2021年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •1) Diagnosis: Adult Myelodysplastic Syndrome (=18 years)
- •2) Revised IPSS: very low. low – intermediate
- •3) Having received 5-20 packed red blood cell units
- •4) Serum ferritin =300 ng/ml
- •5) Transferrin saturation =60%
- •6) Chelation naïve
- •7) Capability to provide informed consent
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1) Patients aged <18 years old
- •2) Higher risk (revised IPSS) MDS (Intermediate 2, high)
- •3) Cumulative transfusion story of > 20 packed red cell units
- •4) Creatinine Clearance (CrCL): <60 ml/min. Patients with CrCl of 40-60ml/min will be included only individually if no other renal risk factors are present
- •5) Serum creatinine >2 x ULN at screening. If borderline serum creatinine will be measured within 7-10 days and the mean value will be used for eligibility criteria
- •6) Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample (or alternatively in two of three samples obtained for screening)
- •7) ECOG performance status >2.
- •8) Left ventricular ejection fraction < 50% by echocardiograph
- •9) A history of repeated hospitalization for congestive heart failure.
- •10) Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
- •11) Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of chronic hepatitis follows EASL 2017 criteria)
- •12) History of HIV positive test result (ELISA or Western blot)
- •13) Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start.
- •14) ALT or AST over 3 times superior to ULN at screening
- •15) ANC < 500/ microL
- •16) Platelets transfusion dependency
- •17) Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study)
- •18) Diagnosis of Child score C liver cirrhosis
- •19) Patients participating in another clinical trial other than an observational registry study
- •20) Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
- •21) History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative
- •22) Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
- •23) Pregnant, intending-to-become pregnant, or breast-feeding patients
- •24) History of drug or alcohol abuse within the 12 months prior to enrollment
- •25) Inability to provide a valid informed consent
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