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University",{"type":60,"coordinates":576},[564,565],{"lat":565,"lon":564},[579,583],{"name":580,"role":48,"phone":581,"phoneExt":27,"email":582},"Xudong Zhang","13633825183","feverxxd@126.com",{"name":580,"role":44,"phone":27,"phoneExt":27,"email":27},{"type":585,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100624422","phase-3-a-phase-iii-study-of-hmpl-760-plus-r-gemox-vs-placebo-plus-r-gemox-in-relapsedrefractory-dlbcl-100624422",false,"NCT07409428","A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed\u002FRefractory DLBCL","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 Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Sign the ICF and be able to follow the requirements of study protocol;\n2. Age ≥18 years;\n3. ECOG performance status score between 0 and 2;\n4. Histopathologically confirmed diagnosis of DLBCL;\n5. The investigator judges that the patient's current condition requires further treatment;\n6. Patients should have at least one bi-dimensionally measurable lesion;\n7. Expected survival is more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;\n2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;\n3. Organ insufficiency;\n4. 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);\n5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;\n6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);\n7. 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);\n8. Clinically significant active infection;","ALL","18 Years",{"count":596,"type":597},240,"ESTIMATED","INTERVENTIONAL",[600],"PHASE3","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\u002FR DLBCL.",[603],"Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma",[24,605,606],"R-GemOx (rituximab, gemcitabine, and oxaliplatin)","R\u002FR DLBCL","2026-03-27",{"date":609,"type":610},"2026-04-01","ACTUAL",{"date":612,"type":610},"2026-03-20",{"date":614,"type":597},"2028-12-30",{"name":5,"class":6},41]