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RECRUITING
NCT06224257
PHASE2

Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.

Official title: A Phase 2, Multicenter, Single-arm, Open-label Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2023-12-03

Completion Date

2026-01-31

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

DRUG

Linperlisib

Elevated PI3K activity in T-LGL likely plays an important role in the ability of the pathologic cells to avoid homeostatic apoptosis, since inhibition of this pathway leads to apoptosis in the population of cells harboring the pathologic clone. More importantly, the activity of this pathway may represent a kind of "Achilles heel" for T-LGL in that PI3K inhibitors alone are quite effective at inducing spontaneous apoptosis in the clonal CTLs after a short incubation.

Locations (3)

Anhui Provincial Hospital

Hefei, Anhui, China

Zhoukou Central Hospital

Zhoukou, Henan, China

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China