A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients With Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 58
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL)
详细描述
This is a multi-center, single-arm, open-label clinical study to evaluate the oral therapy with HMPL-689 in patients with relapsed / refractory MZL and FL. Relapse / refractory is defined as such a situation when a patient has not achieved response (CR or PR) after the latest line of systemic treatment, or has disease progress (PD) or relapse after achieving response. Two (2) cohorts of patients will be enrolled in this study:
Cohort 1: approximately 81 patients with histologically confirmed MZL
Cohort 2: approximately 104 patients with histologically confirmed FL (pathological grade 1-3a)
All patients are to receive monotherapy of HMPL-689 30 mg once a day (QD) continuously in 28-day treatment cycles until PD / recurrence, patient death, intolerable toxicity, initiation of other antitumor therapy, the patient unable to further benefit from the study treatment as judged by the investigators, the patient or his/her legal representative's request to withdraw from the clinical study treatment, the patient lost to follow-up or end of the study, whichever comes first.
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
- •Age ≥18 years;
- •Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;
- •At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (the longest diameter of nodal lesion > 1.5 cm or extranodal lesion > 1 cm);
- •Expected survival of more than 12 weeks;
排除标准
- •Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion;
- •Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);
- •Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor;
- •Inadequate organ function of liver and kidney;
- •Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
- •Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product;
- •Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product;
- •Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment;
- •Pregnant (positive serum pregnancy test) or lactating women;
- •Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, one disease or state providing a reason to suspect that the subject is not suitable for HMPL-689 at the investigator's discretion, or one condition that will affect interpretation of the study results or bring the subject at high risk.
研究组 & 干预措施
Relapsed/Refractory MZL and FL
Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
干预措施: HMPL-689 (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Baseline up to the last patient has completed 12 months after treatment.
Defined as the proportion of patients with CR or PR
次要结局
- Complete response (CR) rate(Baseline up to the last patient has completed 12 months after treatment.)
- Progression-free survival (PFS)(Baseline up to the last patient has completed 12 months after treatment.)
- Time to response (TTR)(Baseline up to the last patient has completed 12 months after treatment.)
- Duration of response (DoR)(Baseline up to the last patient has completed 12 months after treatment.)
- Overall survival (OS)(Baseline up to the last patient has completed 12 months after treatment.)