Status:
COMPLETED
Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Marginal Zone Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 si...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04849351
Start Date
April 15 2021
End Date
February 29 2024
Last Update
April 6 2025
Active Locations (58)
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1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
2
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
4
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191