Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

NCT07409428

RecruitingPhase 3

Sponsor: Hutchmed

Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions: HMPL-760, HMPL-760 Placebo, R-GemOx

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Sign the ICF and be able to follow the requirements of study protocol;
2. Age ≥18 years;
3. ECOG performance status score between 0 and 2;
4. Histopathologically confirmed diagnosis of DLBCL;
5. The investigator judges that the patient's current condition requires further treatment;
6. Patients should have at least one bi-dimensionally measurable lesion;
7. Expected survival is more than 12 weeks;

Exclusion Criteria:

1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
3. Organ insufficiency;
4. 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);
5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
7. 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);
8. Clinically significant active infection;
Locations (50)
  • Shanghai, Shanghai Municipality, China
  • Baoding, China
  • Beijing, China
  • Beijing, China
  • Bengbu, China
  • Changchun, China
  • Changsha, China
  • Changsha, China
  • Changsha, China
  • Chengdu, China
  • Chengdu, China
  • Chongqing, China
  • Chongqing, China
  • Fujian, China
  • Fuzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Guiyang, China
  • Hangzhou, China
  • Hangzhou, China
  • Harbin, China
  • Hefei, China
  • Jinan, China
  • Jinan, China
  • Kunming, China
  • Nanchang, China
  • Nanjing, China
  • Nanjing, China
  • Nanning, China
  • + 20 more on CT.gov