Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas

Inclusion Criteria

• •1. Patients with relapsed or refractory EBV- and CD30-positive lymphomas
• •2. Age ≥ 18 years
• •3. ECOG performance status 0-2
• •4. At least one measurable lesion based on revised Cheson's or modified SWAT criteria
• •5. Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
• •6. Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
• •8. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
• •9. Adequate hematologic function: absolute neutrophil count (ANC) ≥1,500/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC ≥ 1,000/µL and platelet count ≥ 50,000/µL if there is known bone marrow involvement)
• •10. Adequate liver function: total bilirubin \< 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST \< 3 x ULN (AST and AST \< 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
• •11. Adequate renal function: serum creatinine \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute.
• •12. Expected survival \> 3 months