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

Overview

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 Title of Study: “A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

Detailed Description

This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classical 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.

Interventions

  • Drug: brentuximab vedotin
    • 1.8 mg/kg given intravenously (IV)

Arms, Groups and Cohorts

  • Experimental: Brentuximab vedotin

Clinical Trial Outcome Measures

Primary Measures

  • Objective response rate (ORR) per BICR according to Lugano response criteria
    • Time Frame: Up to approximately 1 year
  • Number of participants with adverse events
    • Time Frame: Up to approximately 5 years
  • Number of participants with laboratory abnormalities
    • Time Frame: Up to approximately 1 year

Secondary Measures

  • Duration of response (DOR) per BICR according to Lugano response criteria
    • Time Frame: Up to approximately 5 years
  • Progression-free survival (PFS) per BICR according to Lugano response criteria
    • Time Frame: Up to approximately 5 years
  • Overall survival (OS)
    • Time Frame: Up to approximately 5 years
  • Rate of complete response (CR) per BICR according to Lugano response criteria
    • Time Frame: Up to approximately 1 year
  • ORR per investigator assessment according to Lugano response criteria
    • Time Frame: Up to approximately 1 year
  • DOR per investigator assessment according to Lugano response criteria
    • Time Frame: Up to approximately 5 years
  • PFS per investigator assessment according to Lugano response criteria
    • Time Frame: Up to approximately 5 years
  • Rate of CR per investigator assessment according to Lugano response criteria
    • Time Frame: Up to approximately 5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seattle Genetics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julie Lisano, PharmD, Study Director, Seattle Genetics, Inc.
  • Overall Contact(s)
    • Seattle Genetics Trial Information Support, 866-333-7436, clinicaltrials@seagen.com

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