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.

Conditions

Eligibility

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Brentuximab Vedotin in HL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
Experimental
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: dacarbazine
    375 mg/m^2 every 3 weeks by IV infusion
Experimental
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: bendamustine
    70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
Experimental
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: nivolumab
    3 mg/kg every 3 weeks by IV infusion
Experimental
Part E: Brentuximab Vedotin in HL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
Experimental
Part F: Brentuximab Vedotin in PTCL Patients
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
Amitkumar Mehta
205-996-8400
amitkumarmehta@uabmc.edu

More Details

NCT ID
NCT01716806
Status
Recruiting
Sponsor
Seattle Genetics, Inc.

Study Contact

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

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).

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.