NCT04049825已完成1 期
A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Trial to Evaluate the Safety of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a definite diagnosis of Diffuse large B-cell lymphoma(DLBCL)
- •Patients who have received at least initial standard treatment
- •Patients with measurable lesions (based on International Working Group [IWG] 2014 criteria)
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
- •<Only for dose-expansion stage>
- •Patients who are pathologically diagnosed as CD20 positive lymphoma
- •Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease
排除标准
- •Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation
- •Patients who were refractory to initial standard treatment
- •Patients who have a history of bendamustine administration and are intolerant to bendamustine
- •Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma
- •Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL)
- •<Only for dose-expansion stage>
- •- Patients who have a history of rituximab administration and are intolerant to rituximab
研究组 & 干预措施
Dose Escalation Stage
Experimental
The dose of OPB-111077 in the first cohort will be 200 mg/day, increasing as appropriate to 400 mg/day in the second cohort and then to 600 mg/day in the third cohort.
干预措施: OPB-111077 (Drug)
Dose Expansion Stage
Experimental
4 days on and 3days off of 21-day cycles of OPB-111077 Day 1 of 21-days cycles of rituximab Day 2 and 3 of 21-day cycles of bendamustine
干预措施: OPB-111077 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 23days
The tolerability of OPB-111077 in combination with bendamustine and rituximab
Incidence of Adverse events(AEs)
时间窗: Up to 3 years
Safety of OPB-111077 in combination with bendamustine and rituximab
次要结局
- Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014))(Last dose of study drug (up to 3 years))
研究者
研究点 (1)
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