NCT07189065招募中2 期
An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
Guangzhou Lupeng Pharmaceutical Company LTD.41 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月27日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 41
- 主要终点
- Overall Response Rate
研究概览
简要总结
This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, any gender.
- •Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
- •Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
- •At least one measurable lesion (nodal lesion with longest diameter >1.5 cm, extranodal lesion with longest diameter >1.0 cm).
- •Not planned for autologous stem cell transplantation (ASCT).
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
排除标准
- •Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
- •DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma [such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.] or pathological findings suggesting concomitant FL (any grade).
- •Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
- •Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
- •Previous refractoriness to BTK-targeting drugs.
- •Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.
研究组 & 干预措施
Rocbrutinib
Experimental
干预措施: Rocbrutinib (Drug)
BR/R2
Active Comparator
干预措施: Bendamustine (Drug)
BR/R2
Active Comparator
干预措施: Rituximab (Drug)
BR/R2
Active Comparator
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
次要结局
- Overall Response Rate(Up to 24 Months)
- Complete remission rate(Up to 24 Months)
- Progression Free Survival(Up to 24 months)
- Overall survival(Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.)
- Duration of Response (DOR)(Up to 24 months)
- Time to Response (TTR)(Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.)
- Safety Assessment(From first dose of study drug to 28 days after last dose of study drug)
研究者
研究点 (41)
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