Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
- Registration Number
- NCT04849351
- Lead Sponsor
- Hutchison Medipharma Limited
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Relapsed/Refractory MZL and FL HMPL-689 Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) Baseline up to the last patient has completed 12 months after treatment. Defined as the proportion of patients with CR or PR
- Secondary Outcome Measures
Name Time Method Complete response (CR) rate Baseline up to the last patient has completed 12 months after treatment. Defined as the proportion of patients with CR.
Progression-free survival (PFS) Baseline up to the last patient has completed 12 months after treatment. Defined as the time from the first dose of HMPL-689 to occurrence of PD or death, whichever comes first.
Time to response (TTR) Baseline up to the last patient has completed 12 months after treatment. Defined as the time from the first dose of HMPL-689 to the first objective response.
Duration of response (DoR) Baseline up to the last patient has completed 12 months after treatment. Defined as the time from the initial objective response to disease recurrence, progression or death.
Overall survival (OS) Baseline up to the last patient has completed 12 months after treatment. Defined as the time from the first dose with HMPL-689 to death from any cause.
Trial Locations
- Locations (58)
Ganzhou People's Hospital
🇨🇳Ganzhou, Jiangxi, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Chao-yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing GoBroad Boren Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
The First Hospital of Harbin
🇨🇳Ha'erbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Puyang Oilfield General Hospital
🇨🇳Puyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Gannan Medical University
🇨🇳Gannan, Jiangxi, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
People's Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second People's Hospital of Huaihua
🇨🇳Huaihua, Hunan, China
The Central Hospital of YongZhou
🇨🇳Yongzhou, Hunan, China
The First People's Hospital of Nantong
🇨🇳Nantong, Jiangsu, China
The Second Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
Affiliated Hospital of Binzhou Medical University
🇨🇳Binzhou, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The affiliated hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Cancer Hospital Affiliated to Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China