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

Status
Active
Cancer Type
Hodgkin Lymphoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01716806
Protocol IDs
SGN35-015 (primary)
Study Sponsor
Seagen Inc.

Summary

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.

Objectives

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).

Eligibility

  1. Parts A, B, C, and D: 60 years of age or older
  2. Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  3. Treatment-naive patients with CD30-expressing PTCL (Part F)
  4. Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  5. 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:
  6. A CIRS score of 10 or greater
  7. Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
  8. Measurable disease of at least 1.5 cm as documented by radiographic technique
  9. 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)

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.