Clareo Health | A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
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Keep this study
Lead
Seagen Inc.
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
You may not be if
Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
Existing Grade 2 or higher peripheral neuropathy
Previously refractory to treatment with brentuximab vedotin
History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
Active cerebral/meningeal disease
History of progressive multifocal leukoencephalopathy (PML)
Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
