Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study

Inclusion Criteria:

• Ages 18-75;
• Mycosis fungoides and Sezary syndrome confirmed by histopathology;
• Patients with measurable lesions, with or without extra-cutaneous lesions, andclinical stage IIB-IVB;
• No remission or relapse after at least one systemic therapy (including total bodyelectron irradiation, becarodine, retinoic acid, interferon, photoseparation andreplacement, methotrexate, chidamide, etc.);
• ECOG score of 0-2;
• Adequate bone marrow hematopoietic function: neutrophil count (ANC) ≥1.5×109/L,platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
• Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT<2.5UNL, TBil<1.5ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);

Exclusion Criteria:

• Acute myocardial infarction or unstable angina, congestive heart failure, symptomaticarrhythmia, and significantly prolonged QT interval (> 450ms in men and > 470ms inwomen) within 6 months;
• Uncontrolled active infections;
• Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL isexcluded, hepatitis C virus RNA over 1×103 copies /mL is excluded)
• Pregnant or lactating women;
• Investigators judged that they were not suitable to participate in the study