Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Has not received anti-tumor treatment in the past; 3. 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; 4. Age ≥18 years old, regardless of gender; 5. Whole body physical condition score (ECOG) 0-2