New Genotype-guided Treatment in Newly Diagnosed PTCL

Peripheral T‐cell lymphoma (PTCL) is a heterogeneous disease with dismal outcomes.Standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapyis still the most widely used front‐line treatment of PTCL except Brentuximab‐CHPapplication in anaplastic large cell lymphoma (ALCL). The CR rate ranges from 31%‐56% indifferent studies with different PTCL histology compositions. With the exception forALCL‐anaplastic lymphoma kinase (ALK)‐positive, the 5‐year overall survival (OS) rate isapproximately 30%‐40% for most subtypes of PTCL patients in current situation, remainingas the unmet medical needs in this disease. Based on genetic subtypes in PTCL, and ourprevious study exploring targeted agents plus CHOP based on genetic mutations(Guidance‐03 and Guidance‐04 study), we conducted this multicenter, prospective,randomized, open‐label, controlled trial to evaluate the efficacy and safety ofgenotype‐guided targeted agents plus CHOP (CHOP‐X2) versus cyclophosphamide, doxorubicin,vincristine, and prednisone (CHOP) in patients with PTCL. It includes phase I and phaseII stages. Patients will receceived stardard CHOP for the first cycle and then obtain thegenetic subtypes from tumor NGS befor Cycle 2. In phase I, recommended phase 2 dose(RP2D) of targeted agents will be confirmed. In phase II, patients will receive standardCHOP for the first cycle and then 1:1 be randomized to CHOPX2 or CHOP regimen in fourgenetic subtypes.