A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- HMPL-760
- HMPL-760 Placebo
- R-GemOx
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov