|Secondary Protocol No.
||HM2012-21: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
||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).
||Experimental: A+AVD consists of brentuximab vedotin (ADCETRIS) 1.2 mg/kg plus doxorubicin 25 mg/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2.
Active Comparator: ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2.
||This open-label, randomized, 2-arm, multicenter, phase 3 study will enroll patients into 1 of 2 treatment arms. A+AVD and ABVD will be administered intravenously on Days 1 and 15 of each 28-day
cycle. Patients may receive up to 6 cycles of planned study therapy.
||Patient must have histologically confirmed classical Hodgkin Lymphoma (HL) .
|Applicable Disease Sites
Brentuximab vendotin (ADCETRIS)
DOXORUBICIN HYDROCHLORIDE (ADRIAMYCIN)
||Masonic Cancer Center
||Must be at least 18 years of age, be treatment-naive and have bidimensional measurable disease. Anyone with nodular lymphocyte predominant Hodgkin lymphoma, cerebral/meningeal disease, sensory or peripheral neuropathy or known HIV positive is not eligible. A signed informed consent and HIPAA authorization are required.