NCT04102150已完成2 期
A Phase 2, Multicenter, Open-label, Single-arm Study of Valemetostat Tosylate (DS-3201b) in Patients With Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 24
- 主要终点
- Overall response rate (ORR) assessed by central evaluation organization
研究概览
简要总结
This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).
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
- •Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen
- •Aged ≥20 years or older at the time of signing the informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- •At least 1 evaluable lesion
- •Participants who have defined laboratory criteria
- •Life expectancy ≥ 3 months
排除标准
- •A presence of central nervous system involvement at the time of screening tests
- •Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina
- •≥ Grade 3 neuropathy
- •QT interval corrected using Fridericia's method (QTcF) >470 ms
- •Has an uncontrolled infection
- •Participants who use corticosteroids over 10 mg/day
- •Receipt of allogeneic hematopoietic stem cell transplantation
- •History of, or concurrent, malignant tumors
研究组 & 干预措施
DS-3201b
Experimental
干预措施: Valemetostat Tosylate (Drug)
结局指标
主要结局
Overall response rate (ORR) assessed by central evaluation organization
时间窗: Through the end of the study (within approximately 5 years)
The percentage of participants who were assessed for best overall response, who achieved complete remission (CR), complete remission, unconfirmed (CRu) or partial remission (PR) by central evaluation organization.
次要结局
- Tumor control rate (TCR)(Through the end of the study (within approximately 5 years))
- Best response per tumor lesions(Through the end of the study (within approximately 5 years))
- Duration of response (DOR)(Through the end of the study (within approximately 5 years))
- Overall response rate (ORR) assessed by investigator(Through the end of the study (within approximately 5 years))
- Complete remission rate (CR rate)(Through the end of the study (within approximately 5 years))
- Time to response (TTR)(Through the end of the study (within approximately 5 years))
- Progression-free survival (PFS)(Through the end of the study (within approximately 5 years))
- Overall survival (OS)(Through the end of the study (within approximately 5 years))
研究者
研究点 (24)
Loading locations...
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