NCT07562022招募中3 期
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular 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
- 93
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria
- •Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
- •Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion
- •A measurable or evaluable disease at the time of enrolment
- •ECOG PS 0-2
- •Adequate organ function and bone marrow function
- •Expected survival ≥ 6 months
排除标准
- •Documented refractoriness to lenalidomide.
- •Have lenalidomide exposure within 12 months prior to randomization
研究组 & 干预措施
Rituximab and Lenalidomide
Active Comparator
干预措施: Lenalidomide (Drug)
Rituximab and Lenalidomide
Active Comparator
干预措施: Rituximab (Drug)
SCTB35 and Lenalidomide
Experimental
干预措施: SCTB35 injection (Drug)
SCTB35 and Lenalidomide
Experimental
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to approximately 3 years
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS)
时间窗: Up to approximately 3 years
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
次要结局
- Percentage of Participants Achieving Best Overall Response (BOR)(Up to approximately 3 years)
- Percentage of Participants Achieving CR(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Time to Response (TTR)(Up to approximately 3 years)
- Event-Free Survival (EFS)(Up to approximately 3 years)
- Duration of Complete Response (DOCR)(Up to approximately 3 years)
- Time to Complete Response (TTCR)(Up to approximately 3 years)
- Blood Concentrations of SCTB35(Up to approximately 1 years)
- Anti-drug Antibodies of SCTB35(Up to approximately 3 years)
研究者
研究点 (2)
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