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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U16，当前状态为招募中。登记地点显示中国长沙、苏州、上海有研究中心记录。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
U16 · I 期 / II 期
登记条件中文摘要
年龄范围：18岁至70岁
登记的基本范围为不限性别，年龄18岁至70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。
- The Third Xiangya Hospital of Central South University · 长沙
- The First Affiliated Hospital of Soochow University · 苏州
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine · 上海
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。
- 1. Trial participants voluntarily sign the informed consent form and have good compliance;
- 2. Age ≥18 years and ≤70 years at the time of signing the informed consent form; male or female trial participants are eligible;
- 3. Indication: B-cell non-Hodgkin lymphoma that is CD20-positive as demonstrated by immunohistochemistry (IHC) staining of prior tumor tissue samples or by bone marrow cells, and consistent with the 2017 WHO classification of NHL, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) to large B-cell lymphoma, and high-grade B-cell lymphoma (HGBCL);
- 4. Prior treatment with ≥2 lines of adequate therapy or autologous hematopoietic stem cell transplantation (ASCT). Adequate therapy includes: a) Must have received adequate treatment including anthracyclines and rituximab or other CD20-targeted agents (except for CD20-negative tumors); b) Lines of therapy: best response to first-line treatment was progressive disease (PD), or best response to at least 4 cycles of first-line treatment was stable disease (SD), or best response to at least 6 cycles of first-line treatment was PR; PD again during/after the last line of treatment (second-line or beyond), or best response to at least 2 cycles of the last line of treatment was SD. c) For TFL to large B-cell lymphoma: prior to transformation, the participant must have received adequate treatment for FL, and has relapsed or is refractory during/after the last line of treatment after transformation; if the initial diagnosis is transformed lymphoma, the participant must have received ≥2 lines of therapy and has relapsed or is refractory during/after the last line of treatment;
- 5. In a state of disease relapse or refractoriness at screening: a) Definition of relapse: PD again after achieving response (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractoriness: i. No response to the last treatment: PD during/after the last treatment or best response of SD with a duration of less than 6 months; ii. Relapse or progression after ASCT (confirmed by biopsy), including: relapse or PD within 12 months after ASCT; if salvage therapy was subsequently received, no response to the last treatment (SD or PD);
- 6. According to the Lugano classification for lymphoma response assessment (Cheson 2014), at least 1 CT-measurable lesion (for nodal lesions: defined as long axis \>1.5 cm; for extranodal lesions: long axis should be \>1.0 cm), and a lesion confirmed positive by PET-CT;
- 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- 8. Adequate bone marrow reserve at screening, defined as: absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, absolute lymphocyte count (ALC) ≥ 0.3×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L;
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。
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登记号：NCT05768529；登记信息更新于 2026-10-02；本站同步于 2026-10-08。