2022-500765-27-00招募中3 期
An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients with Hematologic Malignancies Previously Enrolled in Studies with Tafasitamab.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- Incidence and severity of SAEs, AESIs and selective AEs in patients receiving tafasitamab
研究概览
简要总结
To provide continued treatment and evaluation of safety in patients receiving tafasitamab.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Overall trial (overall period)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 MorphoSys/Incyte-sponsored 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) (as defined in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information) who does not agree to follow the contraceptive guidance in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information 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 Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information 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.
结局指标
主要结局
Incidence and severity of SAEs, AESIs and selective AEs in patients receiving tafasitamab
Incidence and severity of SAEs, AESIs and selective AEs in patients receiving tafasitamab
次要结局
未报告次要终点
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (5)
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