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

  • IRB No: AHOD1331

    Protocol Abbrev: AHOD1331

    Principal Investigator: Vincent F. Giusti, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Treatment: Biological: Bleomycin Sulfate

    Therapies Involved: Medication 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