A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

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.

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