Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
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
1 other identifier
interventional
178
1 country
58
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
Typical duration for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2021
CompletedStudy Start
First participant enrolled
April 15, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedApril 6, 2025
April 1, 2025
2.9 years
April 13, 2021
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
Defined as the proportion of patients with CR or PR
Baseline up to the last patient has completed 12 months after treatment.
Secondary Outcomes (5)
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.
Study Arms (1)
Relapsed/Refractory MZL and FL
EXPERIMENTALRelapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Interventions
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Harbin
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, 410900, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
People's Hospital of Wuhan University
Wuhan, Hubei, 430061, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, 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, 425006, China
The First People's Hospital of Nantong
Nantong, Jiangsu, 226001, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, 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, 266000, China
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433, China
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 30002, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
junning Cao, Ph.D
Fudan University
- PRINCIPAL INVESTIGATOR
Zhiming Li, post-doc
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2021
First Posted
April 19, 2021
Study Start
April 15, 2021
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
April 6, 2025
Record last verified: 2025-04