KCT0006858招募中未知
A feasibility study of Ropeginterferon for treatment free remission (TFR) in CML patients who have a sustained deep molecular response
ijeongbu Eulji Medical Center, Eulji University0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) New CML-CP at diagnosis
- •2) Patients > age 19 and Patients < age 75
- •3) BCR-ABL1 transcripts with e13a2 or e14a2 transcripts
- •4) Sustained MR4.5 for more than 24 months
- •5) Signed written informed consent
排除标准
- •1) Any contraindication to any of the interferon
- •2) Documented autoimmune disease at screening or in the medical history
- •3) Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
- •4) Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •5) Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
- •6) History or presence of depression requiring treatment with antidepressant
- •7) Any risk of suicide at screening or previous suicide attempts
- •8) Any significant morbidity or abnormality which may interfere with the study participation
- •9) Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception
- •10) History of active substance or alcohol abuse within the last year
- •11) Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
- •12) Thyroid dysfunction not adequately controlled
- •13) History of major organ transplantation
- •14) History of uncontrolled severe seizure disorder
- •15) Leukocytopenia at the time of screening (< 4.0 x 109/L)
- •16) Thrombocytopenia at the time of screening (< 100 x 109/L)
- •17) History of other malignant disease except CML, including solid tumours and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
研究者
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