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Clinical Study of HMPL-689 fo...

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

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-02-29

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Marginal Zone Lymphoma Follicular Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relapsed/Refractory MZL and FL

Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Group Type EXPERIMENTAL

HMPL-689

Intervention Type DRUG

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

Interventions

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HMPL-689

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

Intervention Type DRUG

Other Intervention Names

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Phosphatidylinositol 3-kinase-δ inhibitor

Eligibility Criteria

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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;
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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junning Cao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Zhiming Li, post-doc

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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