研究项目库 / NCT05533775

Obinutuzumab用于淋巴瘤的I 期 / II 期研究

这是一项关于淋巴瘤的I 期 / II 期研究,登记的药物或干预包括Obinutuzumab;Glofitamab;Rituximab;Ifosfamide;Carboplatin;Etoposide;Tocilizumab,当前状态为招募中。登记地点显示中国成都、广州、南宁有研究中心记录。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I 期 / II 期研究,登记的药物或干预包括Obinutuzumab;Glofitamab;Rituximab;Ifosfamide;Carboplatin;Etoposide;Tocilizumab,当前状态为招募中。登记地点显示中国成都、广州、南宁有研究中心记录。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

Obinutuzumab;Glofitamab;Rituximab;Ifosfamide;Carboplatin;Etoposide;Tocilizumab · I 期 / II 期

登记条件中文摘要

年龄范围:6个月至30岁

登记的基本范围为不限性别,年龄6个月至30岁;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。

  • West China Second University Hospital · 成都
  • Sun Yet-sen University Cancer Center · 广州
  • Guangxi Cancer Hospital of Guangxi Medical University · 南宁

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。

  • * Age 6 months to \< 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \< 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study
  • * Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B
  • * Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
  • * Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
  • * Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants \< 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%
  • * Adequate bone marrow, liver, and renal function
  • * Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
  • * Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months

联系前需要确认

请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。

查看登记信息

登记号:NCT05533775;登记信息更新于 2026-10-06;本站同步于 2026-10-07,中国中心当前名额未经人工确认。

查看原始登记记录