A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients
报名条件（概要）
- 年龄：18 Years – 75 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
Zanubrutinib: 160 mg BID, orally, administered until Cycle 15, 21, or 27, and thereafter until discontinuation criteria are met, disease progression, or unacceptable toxicity.(28d/cycle) Sonrotoclax: Starting from Day 1 of Cycle 3, a 4-week dose-escalation regimen is administered until the target dose of 320 mg QD is reached, then administered orally until Cycle 15, 21, or 27, and thereafter until discontinuation criteria are met, disease progression, or unacceptable toxicity. All patients must complete at least 12 cycles of combination therapy with zanubrutinib and sonrotoclax (C4-C15), with a maximum of 24 cycles of combination therapy (C4-C27). If uMRD6 is not achieved after 24 cycles of combination therapy, patients will receive zanubrutinib monotherapy as maintenance. For patients in whom assessment is feasible, treatment discontinuation may be considered upon achieving uMRD6 at any time point. Otherwise, treatment will be continued until disease progression.
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
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
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）
This study is a prospective, multicenter, open-label, single-arm phase II clinical trial evaluating the efficacy and safety of an MRD-guided, time-limited therapy with zanubrutinib combined with sonrotoclax in previously untreated high-risk CLL/SLL patients.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Huayuan ZHU, MD, phDhuayuan.zhu@hotmail.com+86-13813810650
中国／港澳台研究中心
- Jiangsu Province HospitalNanjing，Jiangsu，China
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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: A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients ClinicalTrials.gov Identifier: NCT07671378 Sponsor: The First Affiliated Hospital with Nanjing Medical University Investigational product: Zanubrutinib and sonrotoclax 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：A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients 试验编号：NCT07671378 申办方：The First Affiliated Hospital with Nanjing Medical University 研究药物：Zanubrutinib and sonrotoclax 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）。