A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
Robert Fallon, MD
Primary Investigator
Overview
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.
Description
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Classical Hodgkin Lymphoma,Childhood Hodgkin Lymphoma
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Age: Between 2 Years - 22 Years
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Gender: All
Inclusion Criteria
Patients with newly diagnosed, pathologically confirmed cHL
Patients must not have received any previous chemotherapy or radiation therapy
Patients must not have received systemic corticosteroids within 28 days of treatment start on this protocol, except as specified
Exclusion Criteria
Patients with nodular lymphocyte-predominant HL
Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents
Patients who are pregnant
Lactating females who plan to breastfeed
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 30 days after the last dose of chemotherapy
Patients known to be positive for human immunodeficiency virus (HIV)
Patients who have received any previous chemotherapy or radiation therapy
Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified
