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

Completed · Phase 2

Conditions studied: Hodgkin Disease, Peripheral T Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01716806

Run by

Seagen Inc.

People needed

131

Starts

2012-10-31

Expected to finish

2023-09-12

Last updated by the study team

2024-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of South Alabama - Mitchell Cancer Institute — Mobile, Alabama, United States
• Alaska Urological Institute — Anchorage, Alaska, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Arizona Cancer Center / University of Arizona — Tucson, Arizona, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Providence St Joseph Medical Center — Burbank, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Wilshire Oncology Medical Group Inc. — Pomona, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Florida Cancer Affiliates — Trinity, Florida, United States
• IACT Health — Columbus, Georgia, United States
• Georgia Cancer Specialists / Northside Hospital Cancer Institute — Sandy Springs, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Illinois Cancer Specialists / Advocate Lutheran General Hospital — Niles, Illinois, United States
• American Oncology Networks LLC — Bethesda, Maryland, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Minnesota Oncology Hematology P.A. — Minneapolis, Minnesota, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Morristown Medical Center/ Carol G. Simon Cancer Center — Morristown, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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