This trial is examining the effectiveness of a new treatment combination for advanced Hodgkin’s lymphoma (HL). The main outcomes to be measured will be the number of patients who experience side effects and response to treatment. This study is being conducted in New York, New Jersey, and Ohio, the United States.
The details
The most commonly used frontline chemotherapy regimen for advanced HL is ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). However, bleomycin is associated with serious lung side effects. Brentuximab vedotin (Adcetris) replaces bleomycin in a new regimen called A+AVD.
This trial is examining the effectiveness of the A+AVD regimen for advanced HL. The main outcome to be measured will be the number of patients who experience a side effect called febrile neutropenia. This is a very low white blood cell count with fever, which can be life-threatening.
Who are they looking for?
This trial is recruiting 180 patients with advanced HL that has not been treated yet.
Patients should not have active infections, brain cancer, liver disease, or cardiovascular disease. Patients should not have neuropathy (numbness or tingling in the hands or feet). Patients must not have had another cancer in the previous 2 years. They also should not have received anti-cancer drugs, drugs that block the immune system or radiation therapy within 12 weeks of beginning the study.
How will it work
This trial will involve one group of patients. All patients will receive 6 cycles of A+AVD treatment. Treatment will be given on day 1 and day 15 of a 28-day cycle. After each dose of A+AVD, patients will receive granulocyte colony stimulating factor (G-CSF) treatment. This is a type of growth factor that helps white blood cells recover after treatment.
The main outcome to be measured will be the number of patients who experience febrile neutropenia. Response to treatment and survival will also be determined.
