Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
This trial is active, not recruiting.
|Treatments||brentuximab vedotin, doxorubicin, bleomycin, vinblastine, dacarbazine|
|Sponsor||Millennium Pharmaceuticals, Inc.|
|Collaborator||Seattle Genetics, Inc.|
|Start date||November 2012|
|End date||December 2019|
|Trial size||1334 participants|
|Trial identifier||NCT01712490, 1025002760, 12/LO/1950, 2011-005450-60, C25003, C25003CTID, JapicCTI-142491, REec-2013-0114, U1111-1161-4937|
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)
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
Modified progression free survival (mPFS) per independent review facility (IRF)
time frame: Date of randomization to mPFS event, for approximately 3 to 5 years
Overall survival rate
time frame: Date of randomization to the date of death, for approximately 5 to 7 years
Male or female participants at least 18 years old.
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.
|Official title||A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma|
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