NCT06142188尚未招募不适用
A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel
Shanghai Ming Ju Biotechnology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world
详细描述
The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Signed informed consent
- •Patients who have been treated with Relma-cel, including those who have received off-label products;
- •If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.
排除标准
- •1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
结局指标
主要结局
ORR
时间窗: 15 years
Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);
次要结局
- Duration of response (DOR)(15 years)
- Progression-Free Survival (PFS)(15 years)
- Adverse events (AEs)(15 years)
- CRR(15 years)
- Overall Survival (OS)(15 years)
研究者
研究点 (2)
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