研究项目库 / NCT04442022

Selinexor (combination therapy)用于淋巴瘤的II 期 / III 期研究

这是一项关于淋巴瘤的II 期 / III 期研究,登记的药物或干预包括Selinexor (combination therapy);Placebo matching for Selinexor (combination therapy);Rituximab (combination therapy);Gemcitabine (combinatio,当前状态为研究进行中,已停止招募。登记地点显示中国南京、苏州、Huangpu、徐汇区等城市有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

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这是一项关于淋巴瘤的II 期 / III 期研究,登记的药物或干预包括Selinexor (combination therapy);Placebo matching for Selinexor (combination therapy);Rituximab (combination therapy);Gemcitabine (combinatio,当前状态为研究进行中,已停止招募。登记地点显示中国南京、苏州、Huangpu、徐汇区等城市有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

药物或干预

Selinexor (combination therapy);Placebo matching for Selinexor (combination therapy);Rituximab (combination therapy);Gemcitabine (combination therapy);Dexamethasone (combination therapy);Cisplatin (combination therapy);Selinexor (continuous therapy);Placebo matching for Selinexor (continuous therapy) · II 期 / III 期

登记条件中文摘要

年龄范围:18岁及以上

登记的基本范围为不限性别,年龄18岁及以上;以下仅摘录8项专业入选条件,需结合英文原文并由研究团队确认。

登记记录列出8项主要排除条件,具体医学含义需结合英文原文并由研究团队确认。

中国哪些地方有记录

以下地点来自登记信息,不代表此刻仍有名额;请向研究中心确认最新情况。

  • Jiangsu Province Hospital · 南京
  • The First Affiliated Hospital of Soochow University · 苏州
  • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School · Huangpu
  • Zhongshan Hospital Fudan University · 徐汇区
  • Huaxi Hospital Sichuan University · 成都
  • The first affiliated Hospital, Zhejiang University · 杭州

入选条件原文摘录

以下为摘录,请打开原始登记查看完整入排标准。

  • * Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).
  • * Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.
  • Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.
  • Maintenance therapy will not be counted as a separate line of systemic therapy.
  • Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.
  • * Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \>1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.
  • * Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent \[%\] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.
  • * Adequate bone marrow function at screening, defined as:

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查看登记信息

登记号:NCT04442022;登记信息更新于 2026-10-02;本站同步于 2026-10-08。

查看原始登记记录