Drug Use Surveillance for ADCETRIS Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia
研究概览
简要总结
The purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.
详细描述
The drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat people with untreated CD30-positive Hodgkin's lymphoma.
This survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma patients on concomitant brentuximab vedotin and AVD in the routine clinical setting. The planned number of observed patients will be approximately 100.
This multi-center observational trial will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated participants
- •CD30-positive participants
- •Participants on concomitant Brentuximab vedotin and AVD
排除标准
- •Participants contraindicated for Brentuximab vedotin
研究组 & 干预措施
Brentuximab vedotin 1.2 mg/kg (body weight)
Brentuximab vedotin 1.2 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every two weeks (up to 12 times). The dose should be adjusted depend on the participant's condition. Participants received interventions as part of routine medical care.
干预措施: Brentuximab vedotin (Genetical Recombination) (Drug)
结局指标
主要结局
Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia
时间窗: Up to 2 weeks after the last dose (approximately 6 months)
Severity grades was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE). Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
次要结局
- Tumor Response Rate Based on Investigator's Assessment(Baseline, Up to 2 weeks after the last dose (approximately 6 months))