Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype （SWIFT）
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype
• Age ≥18 years old and ≤75 years old, male and female;
• Peripheral T-Cell lymphoma with follicular helper of T cell phenotype confirmed by histopathology at the study center, including: ① Angioimmunoblastic T-cell lymphoma (AITL), ②follicular T-cell lymphoma (FTCL), and ③ other nodal PTCL with TFH phenotype;
• Never received chemotherapy, radiotherapy, immunological and biological therapy for lymphoma before;
• Autologous stem cell transplantation is not suitable or the patient refused to accept autologous stem cell transplantation;
• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography / computed tomography (PET/CT) or CT and/or MRI, intranode lesions with long diameter \>1.5cm, short diameter \>1.0cm, or exnode lesions with long diameter \> 1.0 cm; PET CT examination of the lesion showing increased uptake in lymph nodes or extranodal areas (higher than liver) and imaging features consistent with lymphoma can be evaluated.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
• Expected survival ≥ 3 months;
• The following required baseline laboratory data:
‣ .White blood cell，WBC≥3.0×109/L(Bone marrow invasive patient≥2.0×109/L), Absolute neutrophil count，ANC ≥1.5×109/L, （Bone marrow invasive patient≥1.0×109/L), Platelet count (PLT) ≥75×109/L, （Bone marrow invasive patient≥50×109/L) ，Hemoglobin (HB)≥ 80g/L;
⁃ .Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (The liver invasion ≤3.0×ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN（The liver invasion≤5.0×ULN）
⁃ .Renal function：creatinine, Cr≤1.5×ULN
⁃ .Coagulation function： International Normalized Ratio (INR)≤1.5 ×ULN； Prothrombin Time (PT)、Activated Partial Thromboplastin Time (APTT)≤1.5×ULN（Unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time）；
⁃ .Thyroid stimulating hormone (TSH) or free thyroid hormone (FT4) or free triiodothyronine (FT3) were within 10% of normal value (note: abnormal TSH caused by non-autoimmune causes can be included in the group);
• Subjects fully understand and voluntarily participate in this study and sign informed consent