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

Seagen

Status and phase

Terminated

Phase 2

Conditions

Hodgkin Lymphoma

Anaplastic Large Cell Lymphoma

Peripheral T Cell Lymphoma

Treatments

Drug: brentuximab vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03947255

SGN35-028

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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