A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 176
- 试验地点
- 34
- 主要终点
- Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
研究概览
简要总结
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed NHL (DLBCL only for Parts B and C)
- •Relapsed or refractory disease following at least 1 prior systemic therapy
- •Measurable disease of at least 1.5 cm as documented by CT
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
排除标准
- •History of another primary invasive malignancy that has not been in remission for at least 3 years
- •Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
- •B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
- •Known cerebral/meningeal disease
研究组 & 干预措施
Brentuximab vedotin+rituximab
干预措施: brentuximab vedotin (Drug)
Brentuximab vedotin+rituximab
干预措施: rituximab (Drug)
Brentuximab vedotin
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
时间窗: Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
时间窗: Up to 3 years
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
次要结局
- Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis(Up to approximately 3 years)
- Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab(Up to approximately 3 years)
- Complete Remission (CR) Rate by Investigator(Up to approximately 3 years)
- Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis(Up to approximately 3 years)
- Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression(Up to 3 years)
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)(1 day)
- Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)(3 weeks)
- Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis(Up to approximately 3 years)
- Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy(Up to 3 years)
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)(3 weeks)
- Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)(3 weeks)
- Baseline Soluble CD30 Expression(Baseline)