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

Purpose

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.

Conditions

  • Hodgkin Lymphoma
  • Peripheral T Cell Lymphoma
  • Anaplastic Large Cell Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brentuximab vedotin
  • Drug: brentuximab vedotin
    1.8 mg/kg given intravenously (IV)
    Other names:
    • ADCETRIS
    • SGN-35

Recruiting Locations

Tulane University Hospital and Clinic
New Orleans, Louisiana 70112
Contact:
Gaynelle Davis
504-988-6770
gdavis7@tulane.edu

More Details

Status
Recruiting
Sponsor
Seagen Inc.

Study Contact

Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Detailed 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.