JPRN-jRCT2031220583进行中（未招募）1 期
A Phase 1 clinical study of nemtabrutinib (MK-1026) in Japanese participants with hematological malignancies (BELLWAVE-002)
Koh Yasuhiro0 个研究点目标入组 12 人开始时间: 2023年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically confirmed B-cell malignancy:
- •*Chronic lymphocytic leukemia (CLL)
- •*Small lymphocytic lymphoma (SLL)
- •*Waldenstrom's macroglobulinemia (WM)
- •*Lymphoplasmacytic lymphoma (LPL)
- •*Other B-cell neoplasm
- •- Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy
- •- Have the ability to swallow and retain oral medication
- •- Is Japanese
排除标准
- •- Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry
- •- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- •- Known history of human immunodeficiency virus (HIV) infection
- •- Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery,gastrectomy)
- •- Underlying history of severe bleeding disorders
- •- History or concurrent condition of pneumonitis/interstitial lung disease
研究者
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