A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Condition: Hodgkin Lymphoma; Peripheral T Cell Lymphoma; Anaplastic Large Cell Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic
Intervention: brentuximab vedotin
Intervention description: 1.8 mg/kg given intravenously (IV)
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CD30-expression; sALCL; PTCL; cHL; Seattle Genetics

Summary:

      This study will look at whether brentuximab vedotin works and is safe in the re-treatment
      setting. To be in this study, patients must have already received brentuximab vedotin as
      treatment and have cancer that progressed (got worse) after stopping treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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