Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL

Inclusion Criteria:

• 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
• 2. Age≥18, ≤70 years
• 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
• 4. No previous systemic treatment before enrollment.
• 5. At least one measurable lesions according to LUGANO 2014 criteria.
• 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
• 7. Life expectancy ≥3 months.
• 8. Ineligible or decline to receive autologous stem cell transplantation (ASCT).
• 9. Adequate main organ function defined as the following required baseline laboratory data: Absolute neutrophil count (ANC)≥1.5×109/L without given G-CSF within 14 days; Platelet count (PLT)≥75×109/L without given transfusion with 14 days; Hemoglobin (HB)≥8g/dL without given transfusion or erythropoietin; Total bilirubin (TBIL)≤1.5X upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5X ULN; Serum creatinine (Scr)≤1.5X ULN; Left ventricular ejection fraction (LVEF)≥50%; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age was defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
• 10.If there is a risk of pregnancy, all participants (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for entire treatment period up to 120 days after the last dose of investigational drug (or 180 days after chemotherapeutic drug).

Exclusion Criteria:

• 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
• 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
• 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
• 4. Patients undergo interventional clinical trials.
• 5. Concurrent lymphoma with CNS invasion.
• 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• 7. Known allergy to the active ingredients or excipients of IBI376 and CHOP regimens.
• 8. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
• 9. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody.
• 10. Received live vaccine within 30 days prior to initial investigational drug administration (day 1 of cycle 1) (Note: inactivated virus vaccine for injection is allowed within 30 days prior to initial administration, but live attenuated vaccine is not allowed).
• 11. Pregnant or breastfeeding women.
• 12. Any serious uncontrolled systemic disease.
• 13. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.