Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Trial Parameters
Brief Summary
A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype
Eligibility Criteria
Inclusion Criteria: 1. Provide written informed consent for the study. 2. Male or female, age ≥ 18 years and ≤80 years. 3. ECOG PS 0,1 or 2. 4. Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type, c. follicular helper T-cell lymphoma, NOS. 5. At least one measurable disease according to the Lugano 2014 Classification. 6. Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry): (1)Hematology values:Hemoglobin (Hb)≥90g/L,Absolute neutrophil count (ANC) ≥1.5×10 9/L, platelets ≥90×10 9/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN),Total bilirubin ≤1.5 × ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT