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

Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Peripheral T-cell Lymphoma: a Prospective, Multi-center Study

HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono-therapy in PTCL. The combination of duvelisib and romidepsin is highly active for relapsed and refractory PTCLs. The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory PTCLs.

Inclusion Criteria:

• Ages 18-75;

• Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;

• Fulfills the criteria for relapsed/refractory lymphoma;

• There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be > 1.5cm, for measurable extranodal lesion, the longest diameter should be > 1.0cm;

• 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<3UNL, TBil<2ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);

Exclusion Criteria:

• Extranodal natural killer/T cell lymphoma;
• Previously treated with PI3K inhibitors;
• Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (> 450ms in men and > 470ms in women) within 6 months;
• Uncontrolled active infections;
• Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded);
• Pregnant or lactating women;