NCT07637929尚未招募不适用
Non-Interventional Study of Puzolcabtagene Autoleucel Injection for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Chongqing Precision Biotech Co., Ltd0 个研究点目标入组 200 人开始时间: 2026年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Objective response rate after Puzol-cel infusion [Effectiveness]
研究概览
简要总结
Establishing real-world data of Chinese patients with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) treated with Puzolcabtagene Autoleucel Injection to evaluate its effectiveness.
详细描述
Best Overall Response (BOR), including CR and CRi(CR: Complete Remission; CRi: Complete Remission with incomplete hematologic recovery)、Best Complete Remission Rate (CRR)、MRD-negative Objective Response Rate (MRD: Minimal Residual Disease)、Duration of Response (DOR)、Relapse-Free Survival (RFS)、Overall Survival (OS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with r/r B-ALL who receive treatment with Pucicelant Injection at a research center commercially certified by Chongqing Precision Biotech in China, and whose bone marrow tumor cells are confirmed to express CD19 by flow cytometry
- •Patients with essentially normal function of vital organs
- •Patients who voluntarily participate in this study and sign the informed consent form. For patients under 18 years of age, informed consent must also be obtained from their legal guardians
排除标准
- •Patients who test positive for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP).
结局指标
主要结局
Objective response rate after Puzol-cel infusion [Effectiveness]
时间窗: 2 year
Objective response rate includes CR, CRi
次要结局
- Minimal residual disease（MRD）(2 years)
- Best overall response after Puzol-cel infusion [Effectiveness](2 years)
- Overall survival after Puzol-cel infusion [Effectiveness](2 years)
- Duration of response after Puzol-cel infusion [Effectiveness](2 years)
- Relapse free survival after Puzol-cel infusion [Effectiveness](2 years)
- Event free survival after Puzol-cel infusion [Effectiveness](2 years)
- The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel(2 years)
- the incidence of adverse events related to treatment of Puzol-cel infusion(2 years)
- the incidence of adverse event of special interest (AESI) of Puzol-cel infusion(2 years)
- the incidence of RCL of Puzol-cel infusion(2 years)
研究者
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