Clinical Studies Search

Protocol Summary


Protocol No.
PSHCI-15-084
Prinicipal Investigator
McGregor, Lisa
Phase
Phase III
Age Group
Both
Scope
National
Secondary Protocol No.
AHOD1331
Title
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults
Objective
Primary:
1. To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; AdcetrisTM) in the chemotherapy backbone of doxorubicin (Adriamycin), vincristine, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk cHL compared to those treated with ABVE-PC.

Secondary:
1. To determine whether children/adolescents with high-risk cHL treated with Bv-AVEPC have a higher rate of early response (determined by FDG-PET) and a reduction in response-directed radiation therapy (RT) compared to those treated with ABVE-PC.

2. To compare the rate of neuropathy (> Grade 3) among patients treated on the Bv-AVEPC (experimental arm) to patients treated on the ABVE-PC (standard arm).
Applicable Disease Sites
Non-Hodgkin's Lymphoma
Status
Open
Participating Institutions
Hershey Medical Center