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Protocol No. 2012IS041 Principal Investigator Bachanova, Veronika
Phase Phase III
Age Group Adult Scope National
Secondary Protocol No. C25003
Title HM2012-21: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Objective 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).
Treatment 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.
Description 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.
Key Eligibility Patient must have histologically confirmed classical Hodgkin Lymphoma (HL) .
Applicable Disease Sites Hodgkin's Lymphoma
Drugs Involved BLEOMYCIN (BLENOXANE)
Brentuximab vendotin (ADCETRIS)
DACARBAZINE (DTIC)
DOXORUBICIN HYDROCHLORIDE (ADRIAMYCIN)
VINBLASTINE (VELBAN)
Status Open
Participating Institutions Masonic Cancer Center : Veronika Bachanova
Detailed Eligibility 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.
Treatment Type Treatment
Contact Veronika Bachanova Phone:612-625-5469
Email:bach0173@umn.edu
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