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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222441

Enrollment

1334

Registered

2014-03-26

Start date

2012-11-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced classical Hodgkin Lymphoma

Interventions

investigational material(s) Generic name etc : Brentuximab vedotin INN of investigational material : Brentuximab Vedotin (Genetical Recombinatin) Therapeutic category code : 429 Other antitumor agents

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Treatment-naive participants with Ann Arbor Stage III or IV Hodgkin Lymphoma(HL). 2) Histologically confirmed classical HL according to the current World Health Organization (WHO) classification. 3) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (=<)2 4) Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.

Exclusion criteria

Exclusion criteria: 1) Nodular lymphocyte predominant Hodgkin lymphoma 2) Cerebral/meningeal disease, including signs and symptoms of progressive multifocal leukoencephalopathy (PML) 3) Sensory or motor peripheral neuropathy 4) Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose. 5) Known human immunodeficiency virus (HIV) positive 6) 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.

Design outcomes

Primary

Measure	Time frame
efficacy 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

Measure	Time frame
efficacy Overall survival (OS) Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years Date of randomization to the date of death	—

Countries

Japan, Refer to the section, "Other"

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026