Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas

Inclusion Criteria

• •1. Patients must have histologically confirmed non-Hodgkin lymphomas with CD 30 expression. Criteria of positive CD30 expression are defined as in cases with membranous CD30 expression from more than 50% of neoplastic cells.
• •2. Relapsed or progressed disease after two or more than two salvage chemotherapy
• •3. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
• •4. Measurable disease \> 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen/pelvis or CT/positron emission tomography (PET) scans
• •5. Life expectancy of greater than 3 months
• •6. ECOG performance status ≤ 2
• •7. Male or female patients 18 - 75 years
• •8. 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.
• •9. 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.
• •10. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •11. Clinical laboratory values as specified below within 7 days before the first dose of study drug:
• •12. Serum creatinine must be \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute.
• •13. Hemoglobin must be ≥ 8g/dL.
• •14. Absolute neutrophil count (ANC) ≥ 1500/uL
• •15. Platelets (Plts) ≥ 75,000/; G-CSF can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target ANC; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/uL
• •16. Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
• •17. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 X institutional ULN. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver