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

June 7, 2021 updated by: Hutchison Medipharma Limited

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

185

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • zhimin Zhai, Ph.D
    • Beijing
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • yuqing Song, post-doc
      • Beijing, Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
        • Principal Investigator:
          • hongmei Jin, Ph.D
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • Beijing Chao-yang Hospital ，Capital Medical University
        • Contact:
        • Principal Investigator:
          • aijun Liu, Ph.D
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • zhao Wang, Ph.D
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • yao Liu, Ph.D
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian cancer hospital
        • Contact:
        • Principal Investigator:
          • yu Yang, Bachelor
      • Xiamen, Fujian, China, 361001
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • bing Xu, Ph.D
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • zhiming Li, Post-doc
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Principal Investigator:
          • ru Feng, Master
      • Shantou, Guangdong, China, 515031
        • Not yet recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
          • yingcheng Lin, Master
        • Principal Investigator:
          • yingcheng Lin, Master
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • hong Cen, Ph.D
    • Hainan
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • Hainan General Hospital
        • Contact:
        • Principal Investigator:
          • lier Lin, Master
    • Henan
      • Puyang, Henan, China, 410900
        • Not yet recruiting
        • Puyang Oilfield General Hospital
        • Contact:
          • xuejun Guo, Master
        • Principal Investigator:
          • xuejun Guo, Master
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Ling li, Ph.D
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • zunmin Zhu, Ph.D
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Keshu Zhou, Ph.D
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • liling Zhang, Ph.D
      • Wuhan, Hubei, China, 430061
        • Not yet recruiting
        • People's Hospital of Wuhan University
        • Contact:
        • Principal Investigator:
          • weiping Tao, Master
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hui Zhou, Ph.D
      • Yongzhou, Hunan, China, 425006
        • Not yet recruiting
        • The Central Hospital of Yongzhou
        • Contact:
        • Principal Investigator:
          • sijuan Ding, Master
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Not yet recruiting
        • The First People's Hospital of Nantong
        • Contact:
        • Principal Investigator:
          • meihua Ji, Master
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • fei Li, Master
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • sujun Gao, Ph.D
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
        • Principal Investigator:
          • hongwei xue, Ph.D
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Not yet recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • wenhao Zhang, Ph.D
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • junning Cao, Ph.D
    • Shanxi
      • Taiyuan, Shanxi, China, 30002
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
        • Principal Investigator:
          • qiaohua zhang, Bachelor
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital Sichuan University
        • Contact:
        • Principal Investigator:
          • liqun Zou, Ph.D
      • Nanchong, Sichuan, China, 637000
        • Not yet recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
        • Principal Investigator:
          • jin Wei, Master
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Principal Investigator:
          • shiyong Zhou, Ph.D
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Cancer Hospital affiliated to Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • shune Yang, Master
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
        • Principal Investigator:
          • jin Liang, Master
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • haiyan Yang, Ph.D
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Zhen Cai, Ph.D
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Principal Investigator:
          • yi Chen, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 resonance imaging (MRI) (the longest diameter of nodal lesion > 1.5 cm or extranodal lesion > 1 cm);
  5. Expected survival of more than 12 weeks;

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-cell lymphoma (DLBCL);
  3. Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
  4. Inadequate organ function of liver and kidney
  5. Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
  6. Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product
  7. Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product
  8. Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment
  9. Pregnant (positive serum pregnancy test) or lactating women
  10. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relapsed/Refractory MZL and FL
Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Drug: HMPL-689
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Other Names:
  • Phosphatidylinositol 3-kinase-δ inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Baseline up to the last patient has completed 12 months after treatment.
Defined as the proportion of patients with CR or PR
Baseline up to the last patient has completed 12 months after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate
Time Frame: Baseline up to the last patient has completed 12 months after treatment.
Defined as the proportion of patients with CR.
Baseline up to the last patient has completed 12 months after treatment.
Progression-free survival (PFS)
Time Frame: 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.
Baseline up to the last patient has completed 12 months after treatment.
Time to response (TTR)
Time Frame: 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.
Baseline up to the last patient has completed 12 months after treatment.
Duration of response (DoR)
Time Frame: 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.
Baseline up to the last patient has completed 12 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchison Medipharma Limited

Investigators

  • Principal Investigator: junning Cao, Ph.D, Fudan University
  • Principal Investigator: Zhiming Li, post-doc, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-689-00CH3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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