Pilot study of rituximab and brentuximab vedotin with deferred BMT for relapsed classical Hodgkin lymphoma
This study investigates a new combination of drugs for treating a first relapse of Hodgkin lymphoma. Rituximab, an antibody drug for non-Hodgkin lymphomas, might attack the â??cancer stem cellâ?? that causes Hodgkin lymphoma. This study adds rituximab to another drug, brentuximab vedotin, which targets Hodgkin/Reed-Sternberg cells. The goal is to try to kill â??cancer stem cellsâ?? as well as the other cancer cells, so that people might avoid riskier treatments like a stem cell transplant.
To join the study, you must be at least 16 years old, have a first relapse of classical Hodgkin lymphoma (Hodgkin disease), and never have had rituximab or brentuximab vedotin (Adcentris).
Treatment involves up to 8 doses of brentuximab, and up to 10 doses of rituximab. This treatment schedule may change depending on how you are doing: Brentuximab will be given Day 1 of each 21 day (3 week) cycle, for up to 8 cycles. You will first receive brentuximab on Day 1of Cycle 1 and Day 1 of Cycle 2. A PET/CT scan will then be repeated, to see if your lymphoma has decreased. If your lymphoma has decreased enough (either a partial or complete remission) after the first two doses, you will continue with the study treatment; otherwise you will be taken off study. If you continue with the study treatment, brentuximab will continue to be given at the beginning of each cycle (or every 3 weeks) for a total of up to 8 cycles, and also, Rituximab will begin on Day 1 of Cycle 3. The rituximab will be given weekly for 4 weeks, then every three weeks for 4 doses. Then, additional (maintenance) dose of rituximab will be given once every 3 months for two doses.
09/20/2014 04:03 AM