Clinical Trials /

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

NCT01716806

Description:

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
  • Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: SGN35-015
  • NCT ID: NCT01716806

Conditions

  • Hodgkin Disease
  • Peripheral T Cell Lymphoma

Interventions

DrugSynonymsArms
brentuximab vedotinAdcetris; SGN-35Part A: Brentuximab Vedotin in HL Patients
bendamustinePart C: Brentuximab Vedotin + Bendamustine in HL Patients
dacarbazinePart B: Brentuximab Vedotin + Dacarbazine in HL Patients
nivolumabPart D: Brentuximab Vedotin + Nivolumab in HL Patients

Purpose

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

Detailed Description

      This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as
      monotherapy and in combination with other agents as frontline therapy. There are 6 parts of
      the study. The population to be studied includes treatment-naïve patients with classical
      Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell
      lymphoma (PTCL).
    

Trial Arms

NameTypeDescriptionInterventions
Part A: Brentuximab Vedotin in HL PatientsExperimental
  • brentuximab vedotin
Part B: Brentuximab Vedotin + Dacarbazine in HL PatientsExperimental
  • brentuximab vedotin
  • dacarbazine
Part C: Brentuximab Vedotin + Bendamustine in HL PatientsExperimental
  • brentuximab vedotin
  • bendamustine
Part D: Brentuximab Vedotin + Nivolumab in HL PatientsExperimental
  • brentuximab vedotin
  • nivolumab
Part E: Brentuximab Vedotin in HL PatientsExperimental
  • brentuximab vedotin
Part F: Brentuximab Vedotin in PTCL PatientsExperimental
  • brentuximab vedotin

Eligibility Criteria

        Inclusion Criteria:

          -  Parts A, B, C, and D: 60 years of age or older

          -  Treatment-naive patients with histopathological diagnosis of classical Hodgkin
             lymphoma (Parts A, B, C, D, and E)

          -  Treatment-naive patients with CD30-expressing PTCL (Part F)

          -  Ineligible for or have declined initial conventional combination chemotherapy for HL
             (Parts A, B, C, and D)

          -  Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E)
             or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:

               -  A CIRS score of 10 or greater

               -  Requiring assistance with or dependence on other for any instrumental activities
                  of daily living (IADLs)

          -  Measurable disease of at least 1.5 cm as documented by radiographic technique

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
             (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

        Exclusion Criteria:

          -  Symptomatic neurologic disease compromising IADLs or requiring medication

          -  History of progressive multifocal leukoencephalopathy

          -  Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the
             first dose of brentuximab vedotin

          -  Concurrent use of other investigational agents

          -  Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not
             completed 4 weeks prior to first dose of study drug

          -  History of another malignancy within 1 year before first dose of study drug (Parts E
             and F only)

          -  Part D only:

               -  Received any prior immune-oncology therapy

               -  History of known or suspected autoimmune disease

               -  Prior allogeneic stem cell transplant

               -  History of cerebral vascular event within 6 months of first dose of study drug

               -  Active interstitial lung disease that is symptomatic or may interfere with the
                  detection or management of suspected drug-related pulmonary toxicology

               -  Known history of pancreatitis

          -  Parts D, E, and F only:

               -  Known cerebral/meningeal disease related to the underlying malignancy

               -  Systemic treatment with corticosteroids or other immunosuppressive medications
                  within 1 week of enrollment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Time Frame:Through 1 month following last dose; up to approximately 16 months
Safety Issue:
Description:Defined as the proportion of patients with complete response (CR) or (PR)

Secondary Outcome Measures

Measure:Incidence of adverse events
Time Frame:Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Safety Issue:
Description:
Measure:Complete remission (CR) rate
Time Frame:Through 1 month following last dose; up to approximately 16 months
Safety Issue:
Description:Defined as the proportion of patients with CR
Measure:Duration of complete response
Time Frame:Up to approximately 10 years
Safety Issue:
Description:Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death
Measure:Duration of objective response
Time Frame:Up to approximately 10 years
Safety Issue:
Description:Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death
Measure:Progression-free survival
Time Frame:Up to approximately 10 years
Safety Issue:
Description:Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause
Measure:Disease control rate
Time Frame:Up to approximately 10 years
Safety Issue:
Description:Defined as the proportion of patients with CR, PR, or stable disease (SD)
Measure:ORR according to Lugano criteria per BICR (Parts E and F)
Time Frame:Through 1 month following last dose; up to approximately 16 months
Safety Issue:
Description:
Measure:B symptom resolution rate
Time Frame:Through 1 month following last dose; up to approximately 16 months
Safety Issue:
Description:Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period
Measure:Blood concentrations of brentuximab vedotin
Time Frame:Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
Safety Issue:
Description:
Measure:Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
Time Frame:Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
Safety Issue:
Description:Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study
Measure:Blood concentrations of nivolumab (Part D only)
Time Frame:Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
Safety Issue:
Description:
Measure:Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
Time Frame:Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose
Safety Issue:
Description:Defined as the proportion of patients who develop ATA to nivolumab at any time during the study
Measure:Overall survival (Parts E and F only)
Time Frame:Up to approximately 5 years
Safety Issue:
Description:Defined as the time from start of study treatment to date of death due to any cause

Details

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

Trial Keywords

  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Hematologic Diseases
  • Hodgkin Disease
  • Antigens, CD30
  • Lymphoma
  • monomethylauristatin E
  • Drug Therapy
  • CD30-expression
  • PTCL

Last Updated

December 6, 2019