Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.

Inclusion Criteria:Male or female age ≥ 18 yearsDiagnosis of T-cell large granular lymphocytic leukemia (T-LGLL)Meet any of the following indications for treatment：Hemoglobin < 100g/L or RBC transfusion dependenceNeutrophil count <0.5×10^9/L or neutrophil count decreased with recurrent infectionProgressive splenomegaly and/or Massive SplenomegalyCombined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc.Severe B symptomsFailure or intolerance to a first-line therapyECOG performance status ≤2Expected survival ≥ 6 monthsWilling and able to comply with the requirements for this study and written informed consent.Exclusion Criteria:History of other lymphoproliferative neoplasmsHad malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumorsPreviously received organ or stem cell transplantation.Patients with active infection within 2 weeks before giving the first dose of medicationPatients with HBV, HCV, HIV or other infections that require treatmentHistory of immunodeficiency, or congenital immunodeficiency disordersAny severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal valuesRenal impairment: creatinine clearance <60ml/minHistory of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.Received attenuated vaccine 4 in weeks before enrollmentParticipation in another clinical trial within 4 weeks before the start of this trialHave an allergy to Linperlisib or any other part of this medicine.Previously treated with other PI3Kδ inhibitor.Pregnant or breast-feeding patientsPatients considered to be ineligible for the study by the investigator for reasons other than the above