NCT01712490

A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,334 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
DRUG	doxorubicin	Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
DRUG	bleomycin	Bleomycin: 10 units/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
DRUG	vinblastine	Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
DRUG	dacarbazine	Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.

Timeline

• Start date: 2012-11-09
• Primary completion: 2017-04-20
• Completion: 2026-02-02
• First posted: 2012-10-23
• Last updated: 2026-02-27
• Results posted: 2018-11-27

Locations

215 sites across 21 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Hong Kong, Hungary, Italy, Japan, Norway, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study