Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatments brentuximab vedotin, doxorubicin, bleomycin, vinblastine, dacarbazine
Phase phase 3
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

Summary

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

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
brentuximab vedotin ADCETRIS®
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle
doxorubicin Adriamycin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
dacarbazine DTIC
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
(Active Comparator)
ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
doxorubicin Adriamycin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
bleomycin
Bleomycin: 10 units/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
dacarbazine DTIC
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle

Primary Outcomes

Measure
Modified progression free survival (mPFS) per independent review facility (IRF)
time frame: Date of randomization to mPFS event, for approximately 3 to 5 years

Secondary Outcomes

Measure
Overall survival rate
time frame: Date of randomization to the date of death, for approximately 5 to 7 years

Eligibility Criteria

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.

Additional Information

Official title A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Takeda.