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

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
Seattle Genetics, Inc.

Study Contact

Seattle Genetics 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.