NCT06082102招募中3 期
A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 19
- 主要终点
- IRC-assessed PFS
研究概览
简要总结
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
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 (Participant, Care Provider, Investigator)
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 , either sex.
- •Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- •Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:
- •For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements
- •Relapsed or refractory disease.
- •At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
- •ECOG performance status (PS) score of 0-2.
排除标准
- •Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
- •Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
- •Prior treatment with any types of BTK inhibitor.
- •Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
- •Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
研究组 & 干预措施
Orelabrutinib
Experimental
干预措施: Orelabrutinib (Drug)
Orelabrutinib
Experimental
干预措施: Rituximab (Drug)
Comparator
Active Comparator
干预措施: Lenalidomide (Drug)
Comparator
Active Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
IRC-assessed PFS
时间窗: Through study completion, an average of 5 year.
次要结局
未报告次要终点
研究者
研究点 (19)
Loading locations...
相似试验
招募中
3 期
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCLMantle Cell LymphomaNCT06363994InnoCare Pharma Inc.476
招募中
3 期
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT05234684Beijing InnoCare Pharma Tech Co., Ltd.150
进行中（未招募）
3 期
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCLLymphoma, Mantle CellNCT02972840Acerta Pharma BV635
招募中
不适用
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local TherapyMarginal Zone LymphomaNCT06478472The First Affiliated Hospital of Xiamen University36
招募中
2 期
Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System InvolvementCNS LymphomaNCT05926427Ruijin Hospital25