Glofitamab，Polatuzumab Vedotin and GemOx in Refractory/Relapsed Aggressive B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-GemOx as induction therapy in patients with Refractory/Relapsed Aggressive B-Cell Lymphoma.
详细描述
The investigators will evaluate safety and efficacy of G-Pola-GemOx as induction therapy in Refractory/Relapsed Aggressive B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Aggressive B-Cell Lymphoma (Including but not limited to diffuse large B-cell lymphoma, mantle cell lymphoma, Burkitt lymphoma, high-grade B-cell lymphoma, etc. according World Health Organization (WHO) classification;
- •Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
- •Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
- •Patient has not received chemotherapy previously.
- •Anticipated life expectancy at least 3 months
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- •Pregnant or lactating women
研究组 & 干预措施
Induction Therapy
Patients were treated by G-Pola-GemOx as Induction Therapy
干预措施: Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
次要结局
- Overall Survival (OS)(through study completion, an average of 2 years)
- Progression Free Survival (PFS)(2 years])
研究者
Liren Qian
Associate Chief Physician, Associate Professor
Navy General Hospital, Beijing