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 Adults Age 60 and Above

This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). The study will look at brentuximab vedotin alone and combined with other drugs.

NCT01716806
Hematologic, Cancer, Cancer (Heme) - Lymphoma - Hodgkin, Cancer (Heme) - Lymphoma - Other
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naïve patients with CD30-expressing PTCL (Part F)
  • 75+ years of age or 60+ years and have depressed ejection fraction or moderately severe renal dysfunction (Parts E and F only)
  • Ineligible for initial conventional combination chemotherapy for HL (Parts A, B, C, D, E) or CD30-expressing PTCL (Part F), or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • 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

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • 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)

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