Study on Adcetris (Brentuximab Vedotin), Chemotherapy, and Radiation for Treating Young Patients with Advanced Hodgkin Lymphoma

Program Overview

The study aims to find out if using Adcetris (brentuximab vedotin) along with chemotherapy and radiation can effectively treat young patients with advanced Hodgkin Lymphoma. Adcetris is a type of monoclonal antibody that can help stop cancer growth in different ways, such as blocking cancer cells from growing and spreading or helping to kill them. Chemotherapy drugs like etoposide, prednisone, doxorubicin, cyclophosphamide, and dacarbazine work by killing cancer cells or stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. The combination of these treatments may kill more cancer cells and reduce the need for radiation therapy.

Description

Primary Objectives:

• To evaluate the safety and effectiveness of the combination of brentuximab vedotin, etoposide, prednisone, and doxorubicin (AEPA) followed by cyclophosphamide, brentuximab vedotin, prednisone, and dacarbazine (CAPDac) in young patients with high-risk Hodgkin Lymphoma.
• To compare the event-free survival of patients treated with AEPA/CAPDac to previous studies.

Secondary Objectives:

• To estimate the number of patients who respond well after 2 cycles of AEPA.
• To evaluate the safety of Adcetris in the AEPA/CAPDac regimen in children with high-risk Hodgkin Lymphoma.
• To describe side effects related to blood, nerve, and infections, including the need for blood transfusions and hospitalizations.
• To study the link between treatment failure and the original location of the cancer.
• To assess symptoms and quality of life in children with high-risk Hodgkin Lymphoma compared to previous studies.

Treatment Plan:

• AEPA Regimen: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily on days 1 to 15, and doxorubicin on days 1 and 15. This treatment is repeated every 28 days for 2 courses unless the disease progresses or side effects are unacceptable.

• CAPDac Regimen: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin on days 1 and 8, prednisone three times daily on days 1 to 15, and dacarbazine on days 1 to 3. This treatment is repeated every 21-28 days for 4 courses unless the disease progresses or side effects are unacceptable.

• After CAPDac chemotherapy, patients whose lymph nodes do not go into remission after 2 courses of AEPA undergo radiation therapy daily, 5 days a week for 3-4 weeks.

• After completing the study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Eligibility Criteria

Locations