NCT03936153招募中2 期
An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy 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
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 23
- 主要终点
- Clinical effect by evaluating the objective response rate (ORR)
研究概览
简要总结
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
详细描述
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
- •Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;
- •Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
- •Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- •Meet various hematological, liver and renal function lab parameters.
排除标准
- •Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;
- •Toxicity not yet recovered from previous anti-tumor therapies;
- •Uncontrolled systemic infections or infections requiring intravenous antibiotics;
- •Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
- •Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
- •Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
- •Presence of active graft-versus-host reaction;
- •Have undergone a major surgery within the last month;
- •Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
- •Have any cardiac impairment as defined per protocol;
- •Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
研究组 & 干预措施
Abexinostat 80 mg bis in die (BID)
Experimental
Abexinostat 80 mg BID
干预措施: abexinostat (Drug)
结局指标
主要结局
Clinical effect by evaluating the objective response rate (ORR)
时间窗: up to 56 days
To evaluate the objective response rate (ORR) of abexinostat in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as assessed by an independent central imaging review.
次要结局
- Objective Response(up to 56 days)
- Progression-free survival(Up to 2 years)
研究者
研究点 (23)
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