Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- Tumor Response (Central Assessment)
研究概览
简要总结
This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
- •Patients aged ≥20 years on the date of informed consent
- •Patients with histologically confirmed diagnosis of one of the following:
- •Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- •Angioimmunoblastic T-cell Lymphoma (AITL)
- •Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)
- •Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
- •Have at least 1 measurable lesion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Patients with a life expectancy of at least 3 months as determined by the investigator
排除标准
- 未提供
研究组 & 干预措施
SP-02L (darinaparsin for injection)
干预措施: SP-02L (darinaparsin for injection) (Drug)
结局指标
主要结局
Tumor Response (Central Assessment)
时间窗: Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.
Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.
次要结局
- Tumor Response (Local Assessment)(Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.)
- Progression-Free Survival(Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.)
- Overall Survival(Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.)
- Number of Participants With Adverse Events (AEs)(From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.)