A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Location:

Rochester, Minn.

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?

Inclusion Criteria: - Treatment-naïve - Histologically confirmed classical Hodgkin Lymphoma (HL) - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Bidimensional measurable disease Exclusion Criteria: - 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.

Last updated:

9/16/2014

NCT ID:

NCT01712490

IRB Number:

12-006385