Hodgkin Lymphoma Treatment with Brentuximab Vedotin – Phase III

Study of Brentuximab Vedotin for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma in Children and Adolescents

Protocol Description

This multicenter trial by the Children’s Oncology Group 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. Researchers believe that brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders, ages 2 to 18 years, newly diagnosed with classical Hodgkin lymphoma.
Males and Females: Ages 2 to 18 years

Requirements

Patients enrolled in the study will be randomly placed in one of two treatment plans. One will receive standard chemotherapy and the other will receive chemotherapy similar to standard treatment, but with the addition of brentuximab vedotin and the omission of bleomycin. After the 2 initial 21-day cycles, an evaluation will be done with imaging scans to see how the disease is responding. For patients whose condition has not gotten worse, 3 more cycles of chemotherapy will be done, followed by radiation therapy, if needed.
Visits: Same number as required for standard chemotherapy
Duration: 3 to 4 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AHOD1331)
National Cancer Institute

Primary Investigator

Peter Shaw, MD

Contact Information

For more information about the study or enrollment, please contact:
Peter Shaw, MD
412-692-5055