A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed relapsed/refractoryCD30 low (<10%) TCL: including peripheral TCL not otherwise specified (PTCL NOS),angioimmunoblastic T cell lymphoma (AITL), hepato-splenic T cell lymphoma (HTCL),adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL), adult T cell leukemia/lymphoma (ATLL), enteropathy associated T celllymphoma (EATL), NK T cell lymphoma (NK/TCL)

• At least 1 prior chemotherapy regimen

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOGPerformance Status (PS) 3 will be permitted if the decreased PS is attributed to thelymphoma

• Adequate organ function

• Bilirubin ≤1.5X upper limit of normal (ULN), alanine aminotransferase (ALT) andaspartate aminotransferase (AST) ≤3X ULN even in patients with documentedhepatic involvement with lymphoma

• Serum creatinine clearance ≥30 ml/min

• Absolute neutrophil count (ANC) ≥1000/μL (unless documented bone marrowinvolvement with lymphoma)

• Platelet count ≥50,000/μL (unless documented bone marrow involvement withlymphoma)

• At least 6 weeks from autologous stem cell transplantation

• At least 3 months from allogeneic stem cell transplantation and offimmunosuppression and no evidence of graft versus host disease (GVHD)

• Previous treatment with brentuximab vedotin will be allowed if it was done 6 monthsprior to enrollment and patient was not refractory

• Measurable disease ≥1.5 cm seen on computed tomography (CT) scan andFluorodeoxyglucose (FDG) avid disease on positron emission Tomography (PET) scan.Splenomegaly measuring >12 cm, if attributed to TCL and/or positive bone marrowinvolvement with lymphoma are also eligible.

• Females of childbearing potential must have a negative serum or urine pregnancy testresult within 7 days prior to the first dose of study treatment. Women ofchild-bearing age must agree to use an effective contraception method during thestudy and for at least 6 months following the last dose of study drug.

• Males who have partners of childbearing potential must agree to use an effectivecontraceptive method during the study and for 6 months following the last dose ofstudy drug.

• Subjects must have the ability to understand and the willingness to sign a writteninformed consent document

Exclusion Criteria:

• Anaplastic large cell lymphoma (ALCL) both alk positive and negative

• Cutaneous T cell lymphomas except transformed Mycosis fungoides (MF)

• Prior treatment with Brentuximab in the last 6 months or previously refractory toBrentuximab Vedotin (BV) or had progressive disease (PD) while on BV

• Pregnancy or breast feeding women

• Prior malignancy within the past 3 years except non melanoma skin cancer or otherlocalized cancer treated with curative intent

• Presence of grade >2 peripheral neuropathy or patients with the demyelinating formof Charcot-Marie-Tooth syndrome.

• Presence of central nervous system (CNS) involvement requiring active treatment

• History of progressive multifocal leukoencephalopathy (PML)

• Myocardial infarction within the past 6 months

• Patients with the following medical conditions that could affect their participationin the study:

• any active acute or chronic or uncontrolled infection

• liver disease including history of viral hepatitis B or C, evidence ofcirrhosis, chronic active or persistent hepatitis

• a known history of HIV

• symptomatic cardiac disease, including congestive heart failure, coronaryartery disease, and arrhythmias

• Prior hypersensitivity to any component in the ADC formulation

• Treatment with chemotherapy or investigational agents within 2 weeks of start ofstudy treatment