Evidence map›Paper›PMID 22454421›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma.

Anas Younes, Ajay K Gopal, Scott E Smith, Stephen M Ansell, Joseph D Rosenblatt, Kerry J Savage, Radhakrishnan Ramchandren, Nancy L Bartlett, Bruce D Cheson, Sven de Vos and 8 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 602 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
602citing papers in PubMed, 4 pooled it
89.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00848926 phase2completednot on this map

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

TypeinterventionalSponsorSeagen Inc.Ran2009 to 2015Enrolled102ConditionsDisease, HodgkinArmsbrentuximab vedotin
NCT03576378 phase1 / phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy With Cyclophosphamide, Procarbazine, Prednisone, Etoposide and Mitoxantrone (BrEPEM) for Older Patients With Untreated Hodgkin Lymphoma (HL)

TypeinterventionalSponsorGrupo Español de Linfomas y Transplante Autólogo de Médula ÓseaRan2018 to 2024Enrolled41ConditionsHodgkin LymphomaArmsBrentuximabVedotin (BV)
3 · Its place in the literature

Who cites it

602 citing papers in PubMed, 4 syntheses or guidelines pooled it, 1,502 citations in OpenAlex.

  1. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  8. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced NonsquamousJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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  20. Expert consensus on the management of peripheral neuropathy in patients with lymphoma on brentuximab vedotin.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article

542 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Anas YounesThe University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. ayounes@mdanderson.org
Ajay K Gopal
Scott E Smith
Stephen M Ansell
Joseph D Rosenblatt
Kerry J Savage
Radhakrishnan Ramchandren
Nancy L Bartlett
Bruce D Cheson
Sven de Vos
Andres Forero-Torres
Craig H Moskowitz
Joseph M Connors
Andreas Engert
Emily K Larsen
Dana A Kennedy
Eric L Sievers
Robert Chen
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Oncology Research Career Development ProgramK12CA001727 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI MORTIMER, JOANNE E. · 1992 to 2024
$14.6M
NCI NIH HHS K12 CA001727NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeBrentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. PATIENTS AND

methodsIn this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility.

resultsThe ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea.

conclusionThe ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBrentuximab VedotinDisease-Free SurvivalFemaleHodgkin DiseaseHumansImmunoconjugatesMaleMiddle AgedRecurrenceYoung AdultAntineoplastic AgentsBrentuximab VedotinImmunoconjugates

Identifiers

PMID22454421
PMCPMC3646316
OpenAlexW2155256323

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.