Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Last updated: April 3, 2025
Sponsor: Hutchison Medipharma Limited
Overall Status: Completed

Phase

2

Condition

Lymphoma

Marginal Zone Lymphoma

Lymphoma, B-cell

Treatment

HMPL-689

Clinical Study ID

NCT04849351
2020-689-00CH3
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years;

  2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;

  4. At least one measurable lesion by computerised tomography (CT) / magnetic resonanceimaging (MRI) (the longest diameter of nodal lesion > 1.5 cm or extranodal lesion > 1 cm);

  5. Expected survival of more than 12 weeks;

Exclusion

Exclusion Criteria:

  1. Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion;

  2. Known histologic transformation to aggressive lymphomas such as diffuse large B-celllymphoma (DLBCL);

  3. Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor;

  4. Inadequate organ function of liver and kidney;

  5. Currently known active infection with human immunodeficiency virus (HIV), hepatitisB virus (HBV) or hepatitis C virus (HCV);

  6. Having received systemic antitumor therapy or radiotherapy within 4 weeks prior tothe first dose of the investigational product;

  7. Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, exceptalopecia, prior to the first dose of the investigational product;

  8. Complicated with uncontrolled systemic infection requiring intravenous antibiotictreatment;

  9. Pregnant (positive serum pregnancy test) or lactating women;

  10. Any other disease, metabolic abnormality, physical examination abnormality orclinically significant laboratory test abnormality, one disease or state providing areason to suspect that the subject is not suitable for HMPL-689 at theinvestigator's discretion, or one condition that will affect interpretation of thestudy results or bring the subject at high risk.

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: HMPL-689
Phase: 2
Study Start date:
April 15, 2021
Estimated Completion Date:
February 29, 2024

Study 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.

Connect with a study center

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Chao-yang Hospital ,Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing GoBroad Boren Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361001
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong 515031
    China

    Site Not Available

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang, Hebei
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang
    China

    Site Not Available

  • The First Hospital of Harbin

    Ha'erbin, Heilongjiang
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • Puyang Oilfield General Hospital

    Puyang, Henan 410900
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • People's Hospital of Wuhan University

    Wuhan, Hubei 430061
    China

    Site Not Available

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The Second People's Hospital of Huaihua

    Huaihua, Hunan
    China

    Site Not Available

  • The Central Hospital of YongZhou

    Yongzhou, Hunan 425006
    China

    Site Not Available

  • The First People's Hospital of Nantong

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • The Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Gannan Medical University

    Gannan, Jiangxi
    China

    Site Not Available

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi
    China

    Site Not Available

  • Jiangxi Provincial Cancer Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning
    China

    Site Not Available

  • Affiliated Hospital of Binzhou Medical University

    Binzhou, Shandong
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • The affiliated hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Shanghai East Hospital, Tongji University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 30002
    China

    Site Not Available

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan 637000
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang 830000
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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