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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    180
  • sponsor
    Seagen Inc.
Updated on 17 August 2021
lymphoma
hodgkin's disease
measurable disease
chemotherapy regimen
nivolumab
dacarbazine
t-cell lymphoma
peripheral t-cell lymphoma
brentuximab vedotin
bendamustine
brentuximab
classical hodgkin lymphoma

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.

Description

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-nave patients with classical Hodgkin lymphoma (HL) or treatment-nave patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Details
Condition Hodgkin's Disease, Peripheral T-Cell Lymphoma, Lymphoma, T-Cell Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment Nivolumab, Bendamustine, dacarbazine, brentuximab vedotin
Clinical Study IdentifierNCT01716806
SponsorSeagen Inc.
Last Modified on17 August 2021

Eligibility

Yes No Not Sure

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
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