A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

Inclusion Criteria:

   - Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic
   anaplastic large cell lymphoma

   - Measurable disease of at least 1.5 cm

   - ECOG performance status less than or equal to 2

Exclusion Criteria:

   - Known cerebral/meningeal disease, including history of progressive multifocal
   leukoencephalopathy

   - Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis
   fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell
   lymphoma, nasal type

   - History of another primary malignancy that has not been in remission for at least 3
   years

   - Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial
   infarction within the past 12 months

   - Viral, bacterial, or fungal infection within two weeks prior to the first dose of
   brentuximab vedotin

   - Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
   positive status