This clinical trial is for men and women with mature T-cell lymphoma (MTCL) that has never been treated.
The study uses a drug called brentuximab vedotin (also called ADCETRIS) in combination with other drugs approved for use in cancer patients. Brentuximab vedotin is FDA-approved to treat certain types of lymphoma but not for untreated MTCL.
The standard of care for newly diagnosed MTCL is treatment with a combination of drugs called CHOP (cyclophosphamide, hydroxydoxorubicin, vincristine(also called Oncovin), and prednisone). This study is being done to compare CHOP to a combination that replaces vincristine with brentuximab vedotin. This combination is called A+CHP (brentuximab vedotin (ADCETRIS) plus cyclophosphamide, hydroxydoxorubicin, and prednisone).
Brentuximab vedotin is a type of drug called an antibody drug conjugate, or ADC. ADCs usually have two parts—a part that targets cancer cells (the antibody) and the part that kills cancer cells (the chemotherapy). The antibody part of brentuximab vedotin sticks to a target called CD30, an important molecule on some cancer cells. This study will enroll people who have CD30 on their tumor cells.
Study participants will be randomly assigned to receive:
Treatment cycles are 21 days. After completing treatment (approximately 6 months to complete 8 cycles), participants will be followed up for up to 7 years.