Purpose

This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above.

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
  • Ineligible for or have declined initial conventional combination chemotherapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • ECOG performance status less than or equal to 3

Exclusion Criteria

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • 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

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
Brentuximab Vedotin
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: bendamustine
    70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle
  • Drug: dacarbazine
    375 mg/m2 every 3 weeks by IV infusion
  • Drug: nivolumab
    3 mg/kg every 3 weeks by IV infusion
Experimental
Brentuximab Vedotin + Dacarbazine
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: dacarbazine
    375 mg/m2 every 3 weeks by IV infusion
Experimental
Brentuximab Vedotin + Bendamustine
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other names:
    • Adcetris; SGN-35
  • Drug: bendamustine
    70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle
Experimental
Brentuximab Vedotin + Nivolumab
  • 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

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

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.