Spots Global Cancer Trial Database for Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
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Trial Identification
Brief Title: Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Official Title: 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
Study ID: NCT04849351
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Beijing Cancer Hospital, Beijing, Beijing, China
Peking University Third Hospital, 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
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Hainan General Hospital, Haikou, Hainan, China
Puyang Oilfield General Hospital, Puyang, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, 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 Central Hospital of YongZhou, Yongzhou, Hunan, China
The First People's Hospital of Nantong, Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Changchun, Jilin, 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
Shanxi Bethune Hospital, 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
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Contact Details
Name: junning Cao, Ph.D
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Zhiming Li, post-doc
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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