EUCTR2010-022890-33-FR进行中（未招募）不适用
Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes. - Eqol_MDS
ASSOCIAZIONE QOL-ONE0 个研究点目标入组 171 人开始时间: 2015年8月18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
- 入组人数
- 171
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. Adult subjects (18 years of age or older) with low or intermediate-1 IPSS risk MDS (marrow blast < 5%) and stable disease.
- •2. Subjects must have a platelet count taken within the 4 weeks prior to randomization that is <30 Gi/L.
- •3. Subjects must be ineligible or relapsed or refractory to receive other treatment options (such as azacitidine or lenalidomide) and must be ineligible to receive intensive chemotherapy or autologous/allogeneic stem cell transplantation.
- •4. Subjects must have platelet count and platelet transfusion data available over a
- •period of 8 weeks prior to randomization.
- •5. During the 2 months prior to randomization, subjects must have a baseline BM examination (optional in France) which includes cytomorphology and cytogenetics. Histopathology. BM should be performed in case of marrow hypocellularity or if fibrosis is suspected..
- •6. Erythropoiesis-stimulating agents (ESAs) in anemic subjects or granulocyte colonystimulating
- •factor (G-CSF) in subjects with severe neutropenia and recurrent
- •infections are allowed during the study as per accepted standards [23]. Subjects
- •who enter the study on ESAs or G-CSF should continue at the same dose schedule
- •until the optimal dose of study medication has been established.
- •7. ECOG Performance Status < 3 8. Subject is able to understand and comply with protocol requirements and instructions.
- •9. Subject has signed and dated informed consent.
- •10. Adequate baseline organ function defined by the criteria below:
- •total bilirubin (except for Gilbert’s Syndrome) = 1.5xULN
- •ALT and AST = 3xULN
- •creatinine = 2xULN
- •albumin must not be below the lower limit of normal by more than 20%.
- •11. Subject is practicing an acceptable method of contraception. Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >1 year), or of childbearing potential and use of an highly effective method of contraception from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study.
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 86
排除标准
- •1. MDS with intermediate-2 or high IPSS risk
- •2. History of treatment for cancer other than MDS with systemic chemotherapy and/or radiotherapy within the last 2 years.
- •3. History of treatment with romiplostim or other TPO-R agonists.
- •4. Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. persistent atrial fibrillation), or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block).
- •5. BM fibrosis that leads to an inability to aspirate marrow for assessment.
- •6. Peripheral monocytosis > 1000/uL prior to Day 1 of study medication.
- •7. Leukocytosis >=25,000/uL prior to Day 1 of study medication.
- •8. Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test) at screening or pre-dose on Day 1.
- •9. Current alcohol or drug abuse.
- •10. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- •11. Active and uncontrolled infections.
- •12. Subjects infected with Hepatitis B, C or Human Immunodeficiency Virus (HIV).
- •13. History of thrombo-embolic disease
研究者
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