This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as
monotherapy and in combination with other agents as frontline therapy. There are 6 parts of
the study. The population to be studied includes treatment-naïve patients with classical
Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell
lymphoma (PTCL).
Inclusion Criteria:
- Parts A, B, C, and D: 60 years of age or older
- Treatment-naive patients with histopathological diagnosis of classical Hodgkin
lymphoma (Parts A, B, C, D, and E)
- Treatment-naive patients with CD30-expressing PTCL (Part F)
- Ineligible for or have declined initial conventional combination chemotherapy for HL
(Parts A, B, C, and D)
- Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E)
or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
- A CIRS score of 10 or greater
- Requiring assistance with or dependence on other for any instrumental activities
of daily living (IADLs)
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
(Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria:
- Symptomatic neurologic disease compromising IADLs or requiring medication
- History of progressive multifocal leukoencephalopathy
- Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the
first dose of brentuximab vedotin
- Concurrent use of other investigational agents
- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not
completed 4 weeks prior to first dose of study drug
- History of another malignancy within 1 year before first dose of study drug (Parts E
and F only)
- Part D only:
- Received any prior immune-oncology therapy
- History of known or suspected autoimmune disease
- Prior allogeneic stem cell transplant
- History of cerebral vascular event within 6 months of first dose of study drug
- Active interstitial lung disease that is symptomatic or may interfere with the
detection or management of suspected drug-related pulmonary toxicology
- Known history of pancreatitis
- Parts D, E, and F only:
- Known cerebral/meningeal disease related to the underlying malignancy
- Systemic treatment with corticosteroids or other immunosuppressive medications
within 1 week of enrollment