NCT04849351

Clinical Study of HMPL-689 for 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 and Follicular Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Marginal Zone Lymphoma
• Follicular Lymphoma

Interventions

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

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2021-04-19
• Last updated: 2025-04-06

Locations

58 sites across 1 country: China