NCT07709624进行中（未招募）不适用
Evaluating the Treatment Outcomes of Tafasitamab in Patients With Relapsed/ Refractory Diffuse Large B-cell Lymphoma: a Real-world Evidence Study
TTY Biopharm1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12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
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma
*To evaluate best objective response rate (ORR)
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
- •Adult patients aged ≥18 years at the time of tafasitamab initiation.
- •Patients who were initiated on tafasitamab treatment between August 1, 2024, and December 31,
- •Patients with a histologically confirmed diagnosis of DLBCL.
- •Patients ineligible for ASCT based on clinical judgment, comorbidities, or other relevant factors.
- •Patients must have relapsed or refractory disease following at least one prior systemic regimen for DLBCL, with at least one line of therapy including a CD20-targeted agent (e.g., rituximab).
排除标准
- •1. Patients who are alive but unable or unwilling to provide written informed consent.
结局指标
主要结局
objective response rate (ORR)
时间窗: The time from day 1 of tafasitamab treatment initiation to documented disease progression or death
the proportion of patients achieving a complete or partial response to tafasitamab, based on the Lugano 2014 criteria.
次要结局
- TTP (Time to Progression)(the time from day 1 of tafasitamab treatment initiation to tumor progression, with deaths censored if occurring prior to progression)
- TTNT (Time to Next Treatment)(the time from day 1 of tafasitamab treatment initiation to the start of the next anti-neoplastic therapy, regardless of the reason (e.g., disease progression, toxicity, or patient preference) or death from any cause.)
- EFS (Event-Free Survival)(the time from day 1 of tafasitamab treatment initiation to the earliest occurrence of tumor progression, initiation of a new non-study anti-neoplastic therapy, or death from any cause.)
- DoR (Duration of Response)(the time from day 1 of first documented response (complete or partial) to disease progression or death.)
- PFS (Progression-Free Survival)(defined as the time from day 1 of tafasitamab treatment initiation to documented disease progression or death from any cause.)
- OS (Overall Survival)(the time from day 1 of tafasitamab treatment initiation to death from any cause.)
研究者
研究点 (1)
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