At a glance
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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/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
In Brief
A Phase 3 clinical trial evaluating HMPL-760, HMPL-760 Placebo, and 1 other intervention for Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Currently recruiting, targeting 240 participants across 41 sites.
Detailed 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.
Study Details
Timeline
Interventions
Patients will receive HMPL-760 once daily (QD) orally.
Patients will receive HMPL-760 placebo once daily (QD) orally.
R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg/m2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV is given on Day 2 of each cycle.