A Phase II Study of Anti-Programmed Death-1(PD-1) Antibody Sintilimab Plus Histone Deacetylase(HDAC) Inhibitor Chidamide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
• Age range from 18 to 75 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma(ALTL), excluding Nature Killer(NK)/T cell lymphoma);
• At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
• Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate;
• Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal);
• Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml/min);
• Echocardiography or radionuclide cardia functional test, LVEF≥50%;
• Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 2 weeks before enrollment.
⁃ Willingness to provide pathological tissue specimens (20 pieces of wax or paraffin tissue sections);
⁃ Expectation survival time over 3 months;
⁃ Willingness to provide written informed consent.