NCT02452983终止1 期
SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS)
Gustavo Rivero2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Hematological Improvement - minor (HI-minor)
研究概览
简要总结
This study will investigate the effects of sertraline in people with low-risk myelodysplastic syndrome (MDS). It is hoped that sertraline will decrease disease progression and reduce the need for blood transfusions.
详细描述
This pilot study investigates clinical benefit of four 28-day cycles of sertraline in low-risk MDS patients. Participants will receive 100mg of oral sertraline daily. The study will also evaluate potential associated biological mechanisms of action.
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
- •Diagnosis of Very Low or Low risk MDS defined by IPSS-R confirmed by a bone marrow aspirate and biopsy (Blast count must be < 20%)
- •Hemoglobin < 11 g/dL, or transfusion dependency.
- •Platelet count <100,000/mm3
- •Absolute Neutrophil Count (ANC) < 1000/mm3
- •Life expectancy of 12 months or greater
- •ECOG Performance status of 0 - 3
- •Age ≥ 18 years
- •Willing to use medically acceptable methods of birth control during the study and for 28 days after discontinuing study treatment
- •All subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- •Both men and women and members of all races and ethnic groups
排除标准
- •Previous exposure to 5-AC (azacitidine) or decitabine
- •Use of antidepressants such as sertraline within 6 weeks OR use of paroxetine, fluoxetine, or citalopram within 3 months prior to registration
- •Active cases (within past 12 months) of depressive disorder, manic episodes, and/or anxiety requiring active treatment with an SSRI. Patients being treated with an SSRI for non-psychiatric indication are allowed, and should go through the appropriate washout.
- •Previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years
- •Actively receiving chemo-immunotherapy
- •Evidence of active infection
- •Treatment with steroids or immunosuppressive therapy such as cyclosporine, tacrolimus, anti-thymocyte globulin (ATG) within 6 months of registration
- •Platelet transfusion within 8 weeks of registration.
- •Platelet count < 20,000/mm3 within 14 days of registration.
- •Active treatment with growth factors such erythropoietin stimulating agent (ESA), granulocyte colony-stimulating factor (GCSF), thrombopoietin stimulating factor within 8 weeks of registration
- •Treatment with an investigational agent within 4 weeks of registration
- •History of autoimmune disease including rheumatoid arthritis, systemic lupus and sarcoidosis
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sertraline
- •Known history of splenomegaly
- •Pregnant or nursing women are excluded from this study because Sertraline is a Class C agent with the potential for teratogenic or abortive effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sertraline, breast feeding should be discontinued.
- •HIV: Given high risk for Immune thrombocytopenic purpura, HIV associated neutropenia and combination antiretroviral therapy, patients with known HIV are excluded because of the potential for pharmacokinetic interactions with sertraline.
- •Any condition or illness that, in the Investigator's opinion, would place the subject at unacceptable risk if he/she were to participate.
研究组 & 干预措施
Sertraline
Experimental
Sertraline tablets 100mg daily for 4 (28-day) cycles
干预措施: Sertraline (Drug)
Sertraline
Experimental
Sertraline tablets 100mg daily for 4 (28-day) cycles
干预措施: Bone Marrow Aspirate/Biopsy (Procedure)
结局指标
主要结局
Hematological Improvement - minor (HI-minor)
时间窗: 16 weeks
Improvement in erythroid, neutrophil or platelet
次要结局
- Hematological Improvement - major (HI-major) response rate(16 weeks)
- HI-minor response rate(16 weeks)
- Individual rates of HI minor measurements: erythroid, neutrophil and platelet(16 weeks)
- Serum cytokine level modifications(16 weeks)
- Individual rates of HI major measurements: erythroid, neutrophil and platelet(16 weeks)
- Changes in the Gene Expression Profile(Between Baseline and Day 14)
研究者
Gustavo Rivero
Assistant Professor, Principal Investigator
Baylor College of Medicine
研究点 (2)
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