Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
报名条件(概要)
- 年龄:18 Years – 不限
- 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
United States
药品与企业信息
其他名称:RO7082859
"2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.
其他名称:RO5072759, GA101, GAZYVA, GAZYVARO
Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.
其他名称:Polivy
Antibody-drug conjugate, administered via intravenous infusion per protocol.
其他名称:Tecentriq
Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.
其他名称:Actemra
For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.
其他名称:Jaypirca
Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.
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
Tocilizumab
Genentech, Inc.
合作机构
- Genentech, Inc.企业
- Loxo Oncology, Inc.企业
- Eli Lilly and Company企业
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 research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT). The names of the study drugs involved in this research study are: * Glofitamab (a T-cell bispecific humanized monoclonal antibody) * Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody) * Polatuzumab vedotin (an antibody-drug conjugate) * Pirtobrutinib (a selective inhibitor of BTK) * Atezolizumab (a humanized immunoglobulin monoclonal antibody) * Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Celeste Carey, MSceleste_carey@dfci.harvard.edu857-215-1646
- Christine Ryan, MDchristine_ryan@dfci.harvard.edu
研究中心联系方式
- Winship Cancer Institute at Emory UniversityAtlanta,Georgia,United States
- Brigham and Women's HospitalBoston,Massachusetts,United States
- Dana Farber Cancer InstituteBoston,Massachusetts,United States
- The University of North Carolina at Chapel HillChapel Hill,North Carolina,United States
- The Ohio State University Comprehensive Cancer CenterColumbus,Ohio,United States
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: Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation ClinicalTrials.gov Identifier: NCT06043674 Sponsor: Christine Ryan Investigational product: Glofitamab, Obinutuzumab, Polatuzumab Vedotin, Atezolizumab, Tocilizumab 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:Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation 试验编号:NCT06043674 申办方:Christine Ryan 研究药物:Glofitamab、Obinutuzumab、Polatuzumab Vedotin、Atezolizumab、Tocilizumab 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)。