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Marginal Zone LymphomaPhase 2NCT04849351

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

A Phase 2 study testing HMPL-689 in people with Marginal Zone Lymphoma and Follicular Lymphoma, run by Hutchison Medipharma Limited at 58 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone Lymphoma, Follicular Lymphoma
What is being tested?
HMPL-689
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
58 sitesChina
Study dates
15 Apr 2021to 29 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

China58 sites

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing GoBroad Boren Hospital

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Affiliated Hospital of Binzhou Medical University

    Binzhou, Shandong

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Gannan Medical University

    Gannan, Jiangxi

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Hospital of Harbin

    Harbin, Heilongjiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The Second People's Hospital of Huaihua

    Huaihua, Hunan

  • Jinan Central Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Yunnan Cancer Hospital

    Kunming, Yunnan

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

    Luoyang, Henan

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • The First People's Hospital of Nantong

    Nantong, Jiangsu, 226001

  • Puyang Oilfield General Hospital

    Puyang, Henan, 410900

  • The affiliated hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200433

  • Shanghai East Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 30002

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430000

  • People's Hospital of Wuhan University

    Wuhan, Hubei, 430061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001

  • Xingtai People's Hospital

    Xingtai, Hebei

  • The Central Hospital of YongZhou

    Yongzhou, Hunan, 425006

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

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

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)

Read the 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.

Being tested
HMPL-689
Keywords
Marginal Zone Lymphoma, Follicular Lymphoma, Phosphatidylinositol 3-kinase inhibitor
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMPL-689Drug

    Also called Phosphatidylinositol 3-kinase-δ inhibitor

    All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.

Study groups in NCT04849351
Study groupRoleWhat they receive
Relapsed/Refractory MZL and FLExperimentalRelapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Receives: Drug: HMPL-689

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Defined as the proportion of patients with CR or PR

    Measured: Baseline up to the last patient has completed 12 months after treatment.

Secondary outcomes (5)

  1. Complete response (CR) rate

    Defined as the proportion of patients with CR.

    Measured: Baseline up to the last patient has completed 12 months after treatment.

  2. Progression-free survival (PFS)

    Defined as the time from the first dose of HMPL-689 to occurrence of PD or death, whichever comes first.

    Measured: Baseline up to the last patient has completed 12 months after treatment.

  3. Time to response (TTR)

    Defined as the time from the first dose of HMPL-689 to the first objective response.

    Measured: Baseline up to the last patient has completed 12 months after treatment.

  4. Duration of response (DoR)

    Defined as the time from the initial objective response to disease recurrence, progression or death.

    Measured: Baseline up to the last patient has completed 12 months after treatment.

  5. Overall survival (OS)

    Defined as the time from the first dose with HMPL-689 to death from any cause.

    Measured: Baseline up to the last patient has completed 12 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start15 Apr 2021
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849351
Sponsor's protocol ID
2020-689-00CH3
Status last verified
Apr 2025
First submitted
13 Apr 2021
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HMPL-689 in people with Marginal Zone Lymphoma and Follicular Lymphoma, run by Hutchison Medipharma Limited at 58 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Baseline up to the last patient has completed 12 months after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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