Phase 2 Study of Linperlisib Treatment for Adults with Relapsed or Resistant Large Granular T Cell Leukemia

What this Trial Is About

Researchers are evaluating Linperlisib, a PI3K delta inhibitor, in patients with relapsed or refractory large granular T lymphocytic leukemia T-LGLL. This phase 2, multicenter, single-arm study aims to assess the effectiveness and safety of Linperlisib in treating this rare blood cancer. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in China. Participants will receive Linperlisib orally at a dose of 80 mg daily in 28-day cycles. Treatment will continue until the disease progresses or intolerable side effects occur. This single-arm study focuses on monitoring patients over the course of their therapy without using a comparison group. During the study, patients will be regularly evaluated for hematologic remission between 8 to 12 weeks after starting treatment. Researchers will also monitor for any adverse events or side effects. Participant involvement includes clinical assessments, laboratory tests, and safety monitoring throughout the treatment period until disease progression or unacceptable toxicity. The study is expected to complete by January 2026.

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