Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

Inclusion Criteria

• •1. Age \>18 years
• •2. Written informed consent
• •3. Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible:
• •1. Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1
• •2. Systemic anaplastic large cell lymphoma (ALCL) ALK-
• •3. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
• •4. Angioimmunoblastic T-cell lymphoma (AITL)
• •5. Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia virus 1)
• •6. Enteropathy-associated T-cell lymphoma (EATL)
• •7. Hepatosplenic T-cell lymphoma
• •8. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
• •9. Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
• •10. Follicular T-cell lymphoma
• •11. Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
• •4. Positive CD30 expression by local pathology assessment.
• •5. Patients must have at least one measurable disease site. The lesion must be fluorodeoxyglucose (FDG)-avid by PET and must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm by CT, as assessed by the site radiologist.
• •6. Eastern Cooperative Oncology Group (ECOG, Appendix B) performance status of 0 to 1
• •7. Patient must be autologous stem cell transplant (ASCT)-eligible
• •8. Patient must be appropriate candidate for treatment with anthracyclines
• •9. Patient must have the following laboratory criteria at screening:
• •1. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (unless secondary to bone marrow involvement by PTCL)
• •2. Platelet count ≥ 50 x 109/L (unless secondary to bone marrow involvement by PTCL)
• •3. Total serum bilirubin \< 1.5 × upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤3 × ULN
• •4. Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 × ULN, or \<5 × ULN in cases of documented liver involvement by lymphoma
• •5. Serum creatinine clearance must be \>40 mL/minute/1.73m2 either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976, Appendix A) and serum creatinine must be \<175 µmol/L.
• •10. Females of childbearing potential (FCBP) must not be pregnant or breastfeeding and must agree to use at least two effective contraception method during the study and for 6 months following the last dose of treatment.
• •11. Male participants must: Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of treatment.
• •12. In the opinion of investigator, the patient must:
• •1. be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations
• •2. not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative