A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in the Frontline Treatment of Patients with CD30- Positive Mature T-cell Lymphomas
Trial Purpose and Description
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
- Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
- Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- History of another primary invasive malignancy that has not been in remission for at least 3 years
- Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
- History of progressive multifocal leukoencephalopathy (PML)
- Cerebral/meningeal disease related to the underlying malignancy
- Seattle Genetics, Inc.
- Last Updated:
- Study HIC#: