Linperlisib Combined With Chidamide in Patients With PTCL

Inclusion Criteria:

• Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIastudy)

• Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib studyincludes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large celllymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are notincluded.

• ECOG PS 0-2 at protocol entry

• Estimated life expectancy of 6 months or longer

• Measurable disease

• Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrowinvolvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serumglutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement bylymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%

• Women of childbearing potential must use safe anticonception (e.g. contraceptivepills, intrauterine devices etc.) during the study and 12 months after the lastadministration of study drugs; Male patients must use contraception for the durationof the study and 6 months after the last administration of study drugs if hispartner is of childbearing potential

• Written informed consent

Exclusion Criteria:

• Patients previously treated with PI3K inhibitor

• Patients previously treated with chidamide (phase Ib study is not limited by thisitem)

• Suspected or documented central nervous system involvement by lymphoma

• Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection

• Patients with active, uncontrolled infections

• Unwillingness or inability to comply with the protocol

• Deemed 'unfit' by the treating physician

• Pregnant and/or breastfeeding women

• Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related

• Patients with contraindications to chemotherapy

• Known hypersensitivity to one or more of the study drugs