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Not yet recruitingPriority 2 · High priorityNCT06548347

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

ClinicalTrials.gov

Plain-language summary

This Phase 2, Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with a type of T-cell lymphoma called AITL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Linperlisib (DRUG): 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

Drugs / treatments
Linperlisib
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT06548347

Phase: Phase 2, Phase 3 | Status: Not yet recruiting | Priority: High

Plain-language summary

This Phase 2, Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with a type of T-cell lymphoma called AITL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

Linperlisib (DRUG): 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

Drugs / treatments: Linperlisib

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, triple blind

Enrollment target: 606 patients

Primary endpoint: Overall response rate; progression-free survival

Ages: 18 Years to 75 Years

Start date: 2024-09-10 | Est. completion: 2029-09-30

Locations

0 US sites · 0 total

Contact

—

Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. (INDUSTRY)

Tags

AITL/TFH · ALCL · CTCL · ENKTL · MEITL · PTCL-NOS · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06548347

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.