Phase III Randomized Study of HMPL-760 Plus R-GemOx Compared to Placebo Plus R-GemOx in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of HMPL-760 with the R-GemOx regimen compared to placebo with R-GemOx in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase III randomized, double-blind, positive-controlled study aims to assess the efficacy, safety, and pharmacokinetics of HMPL-760 in this patient population. The trial includes multiple phases such as screening, treatment, safety observation, progression-free survival follow-up, and overall survival follow-up. Participants are assigned to one of two groups one group receives HMPL-760 orally once daily in combination with the R-GemOx chemotherapy regimen, and the other group receives a placebo orally once daily with the same R-GemOx regimen. The R-GemOx treatment consists of rituximab given intravenously on Day 1, followed by gemcitabine and oxaliplatin intravenously on Day 2, repeated every 21 days for a total of 8 cycles. The study includes a safety observation period after treatment and long-term follow-up periods to monitor progression-free and overall survival. During the study, participants undergo various assessments including physical exams, safety monitoring, and evaluations of treatment response. Researchers measure progression-free survival, overall survival, response rates, duration of response, clinical benefit, and pharmacokinetics of HMPL-760. These assessments occur up to approximately two years. Participants adherence and safety are closely monitored throughout the trial, which lasts until the study completion date in late 2028.

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