Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04849351
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: