A Multicenter, Prospective and Single-arm Clinical Study on the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma (R/R PTCL) With Chidamide and Duvalisib
To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
• Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World Health Organization in 2008
• Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past. Recurrence is defined as relapse after CR or progression after PR, SD. The refractory disease was defined as previous systemic chemotherapy, PD in response evaluation for 2 cycles or SD in response evaluation for 4 cycles.
• There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion and the measurable lymph node length should be \> 1.5cm;
• Patients aged at 18-75 years old;
• ECOG 0-2
• Routine blood examination: absolute neutrophil count ≥ 1.5× 10 9/L, platelet ≥ 75x10 9/L, Hb ≥ 80g/L.
• Expected survival ≥3 months 8 No radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation was received within 4 weeks before enrollment.
⁃ 9\. The patient or his/her legal representative must provide written informed consent before carrying out any special inspection or procedure of the study.