Genotype-guided Treatment in Newly Diagnosed PTCL
Trial Parameters
Brief Summary
This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.
Eligibility Criteria
Inclusion Criteria: * Histologically-confirmed Peripheral T-cell lymphoma * Availability of archival or freshly collected tumor tissue before study enrollment enough for NGS * Evaluable lesion by PET-CT or CT scan * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 3 months * Informed consent Exclusion Criteria: * Patients with ALCL and cutaneous TCL * Patients with central nervous system (CNS) lymphoma * History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the uppe