Status:
ACTIVE_NOT_RECRUITING
Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
Lead Sponsor:
Hutchmed
Conditions:
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma...
Detailed Description
A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination with R-GemOx versus Placebo in Combination with R-GemOx in Patients with Relap...
Eligibility Criteria
Inclusion
- Sign the Informed consent form(ICF) and be able to follow the requirements of study protocol;
- Age ≥18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2;
- Histopathologically confirmed diagnosis of DLBCL;
- The investigator judges that the patient's current condition requires further treatment;
- Patients should have at least one bi-dimensionally measurable lesion;
- Expected survival is more than 12 weeks;
Exclusion
- Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
- Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
- Organ insufficiency;
- Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV):
- History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
- Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
- Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except for alopecia and decreased appetite);
- Clinically significant active infection;
Key Trial Info
Start Date :
November 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06601504
Start Date
November 5 2024
End Date
November 12 2026
Last Update
June 6 2025
Active Locations (16)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
4
Wuhan Union Hospital of China
Wuhan, Hebei, China