A Randomized, Open-label, Phase 3 Trial of A AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
This is a study of an investigational drug called brentuximab vedotin (ADCETRISÂ®). ADCETRIS targets CD30, a protein on the surface of certain cells that is found on some types of cancers such as Hodgkin lymphoma (HL). ADCETRIS targets CD30 on the cancer cell surface and may cause the cancer cells to die.Another purpose of this study is to see how differences in DNA, RNA and proteins related to HL may influence the way people respond to ADCETRIS. This information may be used to develop a better understanding of how people's genes affect the safety and effectiveness of ADCETRIS; to help develop new ways to monitor and treat cancer; to generate information needed for approval of diagnostic tests related to diseases or conditions that ADCETRIS might treat.
Patients with Hodgkin Lymphoma (HL) who have a confirmed diagnosis of Stage III or IV classical HL that have not beenpreviously treated with systemic chemotherapy or radiotherapy.
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the mPFSobtained with A+AVD against that obtained with ABVD. For this study, the definition of PFS has been modified toinclude the receipt of anticancer chemotherapy or radiotherapy for patients not in CR after the completion of frontlinetherapy as aprogression event in addition to the customary events of disease progression or death due to any cause.All enrolled patients must have a histologically confirmed diagnosis of Stage III or IV classical HL that has not beenpreviously treated with systemic chemotherapy or radiotherapy. Patients will be randomized 1:1 into 1 of 2 treatmentarms:- A+AVD: Brentuximab vedotin 1.2 mg/kg, plus doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine (DTIC) 375mg/m2.- ABVD: Doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, DTIC 375 mg/m2.
09/16/2014 04:03 AM