A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL (NCT07409428) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
China240 participantsStarted 2026-03-20
Plain-language summary
This is a Phase III randomized, double-blind, positive 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 R/R DLBCL.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Sign the ICF and be able to follow the requirements of study protocol;
✓. Age ≥18 years;
✓. ECOG performance status score 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);
✕. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);