Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 110
- 试验地点
- 17
- 主要终点
- Objective Response Rate by Investigator
研究概览
简要总结
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
详细描述
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
- Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
- Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.
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
- •Participated in a previous brentuximab vedotin study.
- •CD30-positive hematologic malignancy.
- •At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
排除标准
- •Withdrew consent to participate in any prior brentuximab vedotin study.
研究组 & 干预措施
BV Retreatment
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
干预措施: brentuximab vedotin (Drug)
BV Extension
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate by Investigator
时间窗: Up to approximately 38 months
Percentage of participants in the retreatment arm 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
时间窗: up to 39 months
Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). 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.
Laboratory Abnormalities >/= Grade 3
时间窗: Up to 39 months
Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
次要结局
- Duration of Objective Response by Kaplan-Meier Analysis(Up to 38 months)
- Progression-free Survival by Kaplan-Meier Analysis(Up to approximately 29 months)
- Overall Survival(Up to approximately 41 months)
- Incidence of Antitherapeutic Antibodies(Up to 39 months)