Clinical Trials /

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

NCT03947255

Description:

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.

Related Conditions:
  • Anaplastic Large Cell Lymphoma
  • Classical Hodgkin Lymphoma
  • Peripheral T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: SGN35-028
  • NCT ID: NCT03947255

Conditions

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

Interventions

DrugSynonymsArms
brentuximab vedotinADCETRIS, SGN-35Brentuximab vedotin

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Brentuximab vedotinExperimental
  • brentuximab vedotin

Eligibility Criteria

        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 ≥3 months after the last dose of
             brentuximab vedotin for subjects treated with brentuximab vedotin in the second line
             or beyond setting, or ≥6 months from the last dose of brentuximab vedotin for subjects
             treated in the frontline setting

          -  Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional
             measureable 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) per BICR according to Lugano response criteria
Time Frame:Up to approximately 1 year
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • CD30-expression
  • sALCL
  • PTCL
  • cHL

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