Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma：a Single-Arm, Open Lable， Multicenter Clinical Trial（LINCH Study）
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
• Histologically confirmed PTCL, including peripheral T-cell lymphoma non-specific type (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma and liver spleen T-cell lymphoma;
• Has not received anti-tumor treatment in the past;
• There must be at least one evaluable lesion/measurable lesion according to the 2014 Lugano Lymphoma Evaluation Criteria. An evaluable lesion is defined as a lymph node or extra-nodal local lesion that shows increased uptake of 18FDG on PET-CT (higher than the liver), with lesion characteristics consistent with lymphoma manifestations. A measurable lesion is defined as a nodule with a longest diameter of \>15mm or an extra-nodal lesion with a longest diameter of \>10mm, accompanied by increased uptake of 18FDG. Exclusion of cases without measurable lesions and diffuse uptake of 18FDG in the liver is required;
• Age ≥18 years old, regardless of gender;
• Whole body physical condition score (ECOG) 0-2;
• Expected survival time\>3 months;
• Adequate bone marrow and organ functions;
• Not accompanied by hemophagocytic syndrome; If the patient is accompanied by clinically diagnosed hemophagocytic syndrome, after targeted anti hemophagocytic syndrome drug treatment, the researcher evaluates the patient's general physical condition to determine whether they can be enrolled.
• Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.