NCT06609304招募中4 期
Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- one year PFS
研究概览
简要总结
The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are:
- Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?
- What medical problems do participants have when receiving axi-cel treatment?
In this investigator-initiated, single-arm clinical trial, participants will:
- Receive atezolizumab treatment at 2.0×10^6 cells/Kg as a one-time therapy.
- Visit the clinic as instructed for checkups and tests.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign the informed consent form;
- •18-70 years of age (inclusive);
- •Previously untreated CD19-positive large B-cell lymphoma;
- •Anticipated survival ≥12 weeks;
- •Adequate bone marrow reserve prior to apheresis
- •Appropriate organ function:
- •Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1;
- •Absence of CNS lymphoma;
- •Negative blood/urine pregnancy test in women of childbearing age.
排除标准
- •History of allergy to any of the components of the cell product;
- •History of stem cell transplantation;
- •History of organ transplantation;
- •Presence of active infections;
- •Current or history of central nervous system disorders;
- •Previous treatment with other modified T-cell therapy;
- •Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
- •Malignancies other than those indicated for this trial;
- •History of any prior systemic immune checkpoint therapy;
- •History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
- •History of a live vaccine within 3 months prior to screening;.
研究组 & 干预措施
axi-cel treatment
Experimental
干预措施: Axicabtagene Ciloleucel (Biological)
结局指标
主要结局
one year PFS
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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