Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

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 Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

Inclusion criteria

• 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 criteria

• 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;