Brentuximab Vedotin for Newly Diagnosed High-Risk cHL

A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents: A Groupwide Phase III Study

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica; Francois, Laetitia Claire; Leffin, Melissa; Spinelli, Jennifer

    Trial Phone: 321.841.3837 ; 321.841.7561 ; 321.841.2008 ; 321.841.5357

  • IRB No: AHOD1331

    Protocol Abbrev: AHOD1331

    Principal Investigator: Vincent F. Giusti, MD

    Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Martin, Rebecca, ARNP; Pope, Michele ARNP; Smith, Amy MD; Story, Allison ARNP; Sullivan, Kelly ARNP; Sutphin, Robert MD; Wieber, Laura ARNP; Levy, Alejandro MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Treatment: Medication

    Applicable Disease Sites: Classical Hodgkin Lymphoma

    Therapies Involved: Biological: Bleomycin Sulfate ID: NCT02166463

  • Objective

    EFS, where events include disease progression or relapse, second malignancy, or death [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ] Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle.

  • Key Eligibility

    Ages Eligible for Study: 2 Years to 18 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No