A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    80
  • sponsor
    Seagen Inc.
Updated on 20 December 2021
cancer
lymphoma
hodgkin's disease
measurable disease
avid
t-cell lymphoma
peripheral t-cell lymphoma
brentuximab vedotin
brentuximab
classical hodgkin lymphoma

Summary

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Description

This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Details
Condition Hodgkin Lymphoma, Peripheral T Cell Lymphoma, Anaplastic Large Cell Lymphoma
Treatment brentuximab vedotin
Clinical Study IdentifierNCT03947255
SponsorSeagen Inc.
Last Modified on20 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

Exclusion Criteria

Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
Existing Grade 2 or higher peripheral neuropathy
Previously refractory to treatment with brentuximab vedotin
History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
Active cerebral/meningeal disease
History of progressive multifocal leukoencephalopathy (PML)
Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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