Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
报名条件(概要)
- 年龄:不限 – 18 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
其他名称:Homoharringtonine injection
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours
其他名称:Cytosar
100mg/m2/q12h for weighing \>10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing \>10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;
其他名称:Etoposide injection
100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours
其他名称:Venclexta
100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd
其他名称:Mitoxantrone hydrochloride liposome injection
5mg/m2/d for weighing \>10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.
其他名称:Recombinant Human Granulocyte Colony-Stimulating Factor Injection
5ug/kg/d, d1-10, s.c., qd, at 1pm
其他名称:Idarubicin hydrochloride injection
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.
其他名称:Nexavar
100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
Venetoclax
AbbVie Inc.
Sorafenib
Bayer HealthCare Pharmaceuticals Inc.
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.
适应症
主动联系研究团队
总联系人(申办方/研究总部)
- Shaoyan Hu, MD, PhDhsy139@126.com+86-13771870462
- Li Gao, MDjoygaoli@163.com+86-15821963190
中国/港澳台研究中心
- First Affiliated Hospital Of University of Science and Technology of ChinaHefei,Anhui,China
- The Second Hospital of Anhui Medical UniversityHefei,Anhui,China
- Guangzhou Women and Children Medical CenterGuangzhou,Guangdong,China
- The First Affiliated Hospital of Guangxi Medical UniversityNanning,Guangxi,China
- Kaifeng Children's HospitalKaifeng,Henan,China
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou,Henan,China
问自己是否符合条件、如何预筛
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML ClinicalTrials.gov Identifier: NCT06221683 Sponsor: Children's Hospital of Soochow University Investigational product: Homoharringtonine, Cytarabine, Etoposide, Venetoclax, Mitoxantrone hydrochloride liposome About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML 试验编号:NCT06221683 申办方:Children's Hospital of Soochow University 研究药物:Homoharringtonine、Cytarabine、Etoposide、Venetoclax、Mitoxantrone hydrochloride liposome 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。