NCT06465433招募中2 期
An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Having been enrolled and is still receiving treatment with tafasitamab at the end of a parent tafasitamab clinical study.
- •Is tolerating tafasitamab treatment at the dose specified in the parent protocol as assessed by the Investigator.
- •Is in complete/partial response or stable disease and is receiving clinical benefit from treatment with tafasitamab in the parent study, as assessed by the Investigator.
- •Has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
- •Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
排除标准
- •Patient who is legally institutionalized, or under judicial protection.
- •Has met one or more criteria for permanent tafasitamab treatment discontinuation as stipulated in the parent protocol.
- •Able to access tafasitamab outside a clinical study.
- •Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- •A female patient who is pregnant confirmed by a pregnancy test prior to enrollment, breastfeeding, or a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment, and does not refrain from donating oocytes during this period.
- •A male patient who does not agree to use contraception as detailed in the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment (if they have a heterosexual partner who is a woman of childbearing potential) and who does not refrain from donating sperm during this period.
研究组 & 干预措施
Tafasitamab Dose
Experimental
Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.
干预措施: Tafasitamab (Drug)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: up to approximately 2 years
Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.
次要结局
未报告次要终点
研究者
研究点 (5)
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