This study is evaluating the effectiveness of brentuximab vedotin (Adcetris) plus chemotherapy for children with advanced Hodgkin lymphoma (HL). The main outcome to be measured will be the number of patients who respond to treatment.
The details
Brentuximab vedotin is being tested to treat children who have advanced HL. Brentuximab vedotin is a monoclonal antibody. This type of treatment helps the body’s immune system to attack cancer cells. It specifically targets cancer cells while leaving healthy cells alone. This can help reduce side effects. The effectiveness and safety of brentuximab vedotin in children with advanced HL are under investigation.
This study is evaluating the effectiveness and safety of brentuximab vedotin plus chemotherapy for pediatric patients with advanced HL. The main outcome to be measured will be the overall response rate (how many patients respond to treatment). The number of patients who have a complete disappearance of cancer (complete response rate) will also be measured.
Who are they looking for?
This trial is recruiting 55 patients with 5-17 years of age with advanced HL. Patients should not have had previous treatment for HL.
Patients with nodular lymphocyte predominant HL (NLPHL) cannot participate in this study. Patients with brain cancer or neurological disease that requires medications cannot participate. Patients with numbness, tingling, or loss of sensation in the limbs, hands, or feet cannot participate.
How will it work
All patients will receive brentuximabvedotin plus chemotherapy (doxorubicin, vinblastine, dacarbazine).
The main outcomes to be measured will be the overall response and the complete response rates. The number of patients who experience side effects will also be measured. Patients will be followed for up to 30 days after the last dose of treatment. Then, patients will be followed for up to 2 years. This study will take approximately 55 months.
