Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Participants who Experienced Peripheral Neuropathy
研究概览
简要总结
This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Brentuximab Vedotin especially myelosupression, peripheral neuropathy, and lung disorder.
During the study, pediatric participants with HL will take Brentuximab Vedotin injection and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. The study doctors will check for side effects from Brentuximab Vedotin for 26 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive participants
- •CD30 positive participants
- •Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
- •Participants aged < 18 years at the start of this drug.
排除标准
- •Participants with contraindications to the study drug.
研究组 & 干预措施
Brentuximab Vedotin
Participants will receive Brentuximab Vedotin injection 50 mg once every 2 weeks and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine).
干预措施: Brentuximab Vedotin (Drug)
结局指标
主要结局
Percentage of Participants who Experienced Peripheral Neuropathy
时间窗: Up to 26 Weeks
Percentage of Participants who Experienced Lung Disorder
时间窗: Up to 26 Weeks
Percentage of Participants who Experienced Myelosuppression
时间窗: Up to 26 Weeks
次要结局
- Percentage of Participants with Adverse Event (AE) Leading to Brentuximab Vedotin Discontinuation, Serious Adverse Event (SAE), and Grade 3 or Higher Adverse Event (AE)(Up to 26 Weeks)
- Percentage of Participants Who Achieve or Maintain Any Best Response(Up to 26 Weeks)