A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 12
- 试验地点
- 19
- 主要终点
- Number of Participants With Laboratory Abnormalities
研究概览
简要总结
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
详细描述
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
- •Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
- •Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
- •Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- •Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
排除标准
- •Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
- •Existing Grade 2 or higher peripheral neuropathy
- •Previously refractory to treatment with brentuximab vedotin
- •History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
- •History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
- •Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
- •Active cerebral/meningeal disease
- •History of progressive multifocal leukoencephalopathy (PML)
- •Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
- •Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
研究组 & 干预措施
Brentuximab vedotin
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Number of Participants With Laboratory Abnormalities
时间窗: Up to 36 months
Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
时间窗: Up to 18.3 months
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Number of Participants With Adverse Events
时间窗: Up to 36 months
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
次要结局
- Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria(Up to 17.1 months)
- Overall Survival (OS)(Up to 35.8 months)
- ORR Per Investigator Assessment According to Modified Lugano Response Criteria(Up to 18.3 months)
- DOR Per Investigator Assessment According to Modified Lugano Response Criteria(Up to 17.1 months)
- Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria(Up to 18.3 months)
- ORR Per BICR According to Lugano Response Criteria(Up to 18.3 months)
- Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria(Up to 18.3 months)
- Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria(up to 18.3 months)
- Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria(Up to 18.3 months)