A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 131
- 试验地点
- 54
- 主要终点
- Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
研究概览
简要总结
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
详细描述
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parts A, B, C, and D: 60 years of age or older
- •Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
- •Treatment-naive patients with CD30-expressing PTCL (Part F)
- •Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
- •Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
- •A CIRS score of 10 or greater
- •Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
- •Measurable disease of at least 1.5 cm as documented by radiographic technique
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
排除标准
- •Symptomatic neurologic disease compromising IADLs or requiring medication
- •History of progressive multifocal leukoencephalopathy
- •Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
- •Concurrent use of other investigational agents
- •Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
- •History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
- •Part D only:
- •Received any prior immune-oncology therapy
- •History of known or suspected autoimmune disease
- •Prior allogeneic stem cell transplant
- •History of cerebral vascular event within 6 months of first dose of study drug
- •Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
- •Known history of pancreatitis
- •Parts D, E, and F only:
- •Known cerebral/meningeal disease related to the underlying malignancy
- •Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
研究组 & 干预措施
Part F: Brentuximab Vedotin in PTCL Patients
干预措施: brentuximab vedotin (Drug)
Part A: Brentuximab Vedotin in HL Patients
干预措施: brentuximab vedotin (Drug)
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
干预措施: brentuximab vedotin (Drug)
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
干预措施: dacarbazine (Drug)
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
干预措施: brentuximab vedotin (Drug)
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
干预措施: bendamustine (Drug)
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
干预措施: brentuximab vedotin (Drug)
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
干预措施: nivolumab (Drug)
Part E: Brentuximab Vedotin in HL Patients
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
时间窗: Up to 81 months
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
时间窗: Up to 60 months
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
时间窗: Up to 31 months
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
次要结局
- Disease Control Rate(Up to 81 months)
- ORR According to Lugano Criteria Per BICR (Parts E and F)(Up to 31 months)
- Number of Participants With Adverse Events(Up to 122 months)
- Number of Participants With Laboratory Abnormalities(Up to 30 months)
- Complete Response Rate(Up to 81 months)
- Duration of Complete Response(Up to 81 months)
- Duration of Objective Response(Up to 81 months)
- Progression-free Survival(Up to 83 months)
- B Symptom Resolution Rate(Up to 42 weeks)
- Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)(Up to 30 months)
- Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)(Up to 30 months)
- Overall Survival (Parts E and F Only)(Up to 44 months)