A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Trial status: Open for Enrollment
Why is this study being done?
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
Who is eligible to participate?
- Histologically confirmed classical Hodgkin Lymphoma (HL)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Bidimensional measurable disease
- Nodular lymphocyte predominant Hodgkin lymphoma
- Cerebral/meningeal disease, including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
- Pulmonary diffusion capacity > 25% lower than normal predicted value
- Sensory or motor peripheral neuropathy
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.