A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
18 Years and older, Male and Female
Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment
for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study
will be older or will have other conditions that make them unable to have standard
chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with
other drugs.
Objectives
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).
Eligibility
- 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)
Treatment Sites in Georgia
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