NCT03934567进行中（未招募）2 期
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 Follicular Lymphoma (FL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 26
- 主要终点
- Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
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 oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)
详细描述
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
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
- •Life expectancy ≥ 3 months
- •Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
- •Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
- •Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
- •Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Meet various hematological, liver function and renal function lab parameters
排除标准
- •Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
- •Current or history of central nervous system (CNS) lymphoma;
- •Toxicity not yet recovered from previous anti-tumor therapies
- •Uncontrolled systemic infections or infections requiring intravenous antibiotics
- •Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
- •Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
- •Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
- •Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
- •Presence of active graft-versus-host disease
- •Have undergone a major surgery within 28 days
- •Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
- •Have cardiac impairment as defined per protocol
- •Have prior history of malignancies other than follicular lymphoma
研究组 & 干预措施
Abexinostat 80 mg bis in die (BID)
Experimental
Experimental: Abexinostat 80 mg BID
干预措施: Abexinostat (Drug)
结局指标
主要结局
Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
时间窗: up to 56 days
Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) 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 (26)
Loading locations...
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