NCT06548347

A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

A International Multicenter, Randomized, Double-Blind, Controlled Phase II/III Study to Evaluate the Efficacy and Safety of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 606 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II/III, international multiple center study to evaluate the efficacy, safety, and PK of Linperlisib plus CHOP and CHOP in adult patients with Newly Diagnosed Peripheral T Cell Lymphoma.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Linperlisib	Linperlisib at 80 mg orally once daily (QD) or 60mg orally once daily (QD) plus CHOP, placebo at 80mg or 60 mg orally once daily (QD) plus CHOP for 6 cycles

Timeline

• Start date: 2024-09-10
• Primary completion: 2024-12-31
• Completion: 2029-09-30
• First posted: 2024-08-12
• Last updated: 2024-08-12