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Keep this study
Lead
Seagen Inc.
With
Bristol-Myers Squibb
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
