JPRN-jRCT2080224880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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients with relapsed or refractory 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
- •- Subject who has 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 (ex. Chronic congestive heart failure, unstable angina)
- •- >= Grade 3 neuropathy.
- •- QTcF >470 ms
- •- Has an uncontrolled infection.
- •- Subject who use of corticosteroids over 10 mg/day
- •- Receipt of allogeneic hematopoietic stem cell transplantation.
- •- History of, or concurrent, malignant tumors.
研究者
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