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Home»Hodgkin's lymphoma» Looking for young Hodgkin lymphoma patients to test the safety and effectiveness of combined treatment with brentuximab vedotin and chemotherapy
Clinical Trial
Looking for young Hodgkin lymphoma patients to test the safety and effectiveness of combined treatment with brentuximab vedotin and chemotherapy
This phase 3 trial aims to test the safety and effectiveness of a combined treatment with brentuximab vedotin (BV; Adcetris) and combination chemotherapy in younger patients with recently diagnosed Hodgkin lymphoma. The main outcome to be measured will be the side effects related to treatment and the response of the tumor to the treatment. This trial is recruiting in the United States, Canada and Puerto Rico.
The details
BV is an antibody that targets the protein CD30. This protein is present on many Hodgkin lymphoma cells. Chemotherapy is the standard treatment for Hodgkin lymphoma. Different chemotherapies act against tumor cells in different ways. They may kill the cells or stop them from dividing or spreading. It is not clear if lymphoma patients would benefit from the combined treatment with chemotherapy and BV.
The current trial will examine the combination treatment of chemotherapy and BV in young patients. The main outcomes to be measured will include the event free-survival (time from treatment until cancer progression or death) and treatment side effects.
Who are they looking for?
This trial will recruit 600 children with stage 2B, 3 or 4 Hodgkin lymphoma. Patients must have normal blood levels and must not have any immune disease, be pregnant or breastfeeding, have HIV, have received chemotherapy before, or corticosteroids within 28 days before starting this trial.
How will it work
All patients will be randomly assigned to receive BV in combination with chemotherapy or chemotherapy alone.
Patients in the chemotherapy alone group will receive treatment by injections on different days. Patients will receive doxorubicin hydrochloride over 1 to15 minutes on days 1 and 2, bleomycin over 10 minutes on days 1 and 8, vincristine over 1 minute on days 1 and 8, etoposide over 60 to 120 minutes on days 1 to 3, prednisone on days 1 to 7 and cyclophosphamide over 30 to 60 minutes on days 1 and 2.
Patients in the combination group will receive BV by injection over 30 minutes on day 1 and the combined chemotherapy as described above and vincristine sulfate over 1 minute on day 8.
Treatment repeats every 21 days for 5 treatment courses or until disease progression or toxicity. The tumor response rate will be determined and side effects reported.
