Evidence map›Paper›PMID 24919462›Full record

Trial reportJournal of hematology & oncology2014

A phase II study of dacetuzumab (SGN-40) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) and correlative analyses of patient-specific factors.

Sven de Vos, Andres Forero-Torres, Stephen M Ansell, Brad Kahl, Bruce D Cheson, Nancy L Bartlett, Richard R Furman, Jane N Winter, Henry Kaplan, John Timmerman and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of hematology & oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00435916 (A Phase II Study of SGN-40), which is not on this map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT00435916 phase2completednot on this map

A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

TypeinterventionalSponsorSeagen Inc.Ran2006 to 2009Enrolled46ConditionsLymphoma, Large B-Cell, Diffuse, Lymphoma, Non-HodgkinArmsSGN-40
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Agonist Antibodies for Cancer Immunotherapy: History, Hopes, and Challenges.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. FcγRs and Their Relevance for the Activity of Anti-CD40 Antibodies.International journal of molecular sciences · 2022
    Review
  17. Finding the Right Heavy Chains for Immunostimulatory Antibodies.International journal of molecular sciences · 2022
    Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Sven de VosDavid Geffen School of Medicine at UCLA, University of California Los Angeles, 650 Charles E, Young Drive 11-934 Factor Bldg, Los Angeles, CA 90095-1678, USA. deVos@mednet.ucla.edu.
Andres Forero-Torres
Stephen M Ansell
Brad Kahl
Bruce D Cheson
Nancy L Bartlett
Richard R Furman
Jane N Winter
Henry Kaplan
John Timmerman
Nancy C Whiting
Jonathan G Drachman
Ranjana Advani
Seagen (United States) · USUniversity of California, Los Angeles · USCornell University · USGeorgetown University · USNorthwestern University · USStanford Medicine · USUniversity of Alabama at Birmingham · USUniversity of Wisconsin–Madison · USWashington University in St. Louis · USWinnMed · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
NCI NIH HHS P30 CA014520
6 · The paper itself

Abstract

backgroundPatients with DLBCL who are ineligible for or have relapsed after aggressive salvage chemotherapy have a poor prognosis. CD40 is expressed on multiple B-cell neoplasms including DLBCL and is a potential target for immunotherapy. Dacetuzumab (SGN-40), a non-blocking, partial agonist, humanized IgG1, anti-CD40 monoclonal antibody, has previously demonstrated anti-lymphoma activity in a phase I study.

methodsA phase II study was undertaken to evaluate the rate and duration of objective responses and safety of single-agent dacetuzumab in relapsed DLBCL. Forty-six adult patients with relapsed/refractory DLBCL received up to 12 cycles of intravenous dacetuzumab using intrapatient dose-escalation to a target dose of 8 mg/kg/week in an initial 5-week cycle, followed by 4-week cycles of 8 mg/kg/week. Study endpoints included rate and duration of objective responses, safety, survival, pharmacokinetics, immunogenicity, and exploratory correlative studies.

resultsOverall response rate was 9% and disease control rate (complete remission + partial remission + stable disease) was 37%. Common non-hematologic adverse events (AEs) included fatigue, headache, chills, fever, and nausea. The most frequent Grade 3-4 non-hematologic AE was deep venous thrombosis (3 patients). Grade 3-4 lymphopenia (41%), neutropenia (13%), or thrombocytopenia (19%) occurred without associated infection or bleeding. Reversible ocular events, including conjunctivitis and ocular hyperemia, occurred in 8 patients (17%). Patient-specific factors, including Fc-gamma-RIIIa polymorphism, did not appear to correlate with antitumor activity.

conclusionsSingle-agent dacetuzumab has modest activity and manageable toxicity in unselected patients with relapsed DLBCL. Combination regimens and robust methods of patient selection may be necessary for further development.

trial registrationClinicalTrials.gov identifier NCT00435916.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCD40 AntigensChillsDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHeadacheHumansKaplan-Meier EstimateLymphoma, Large B-Cell, DiffuseLymphopeniaAntibodies, Monoclonal, HumanizedCD40 AntigensdacetuzumabFc gamma receptor IIAFCGR3A protein, humanReceptors, IgG

Identifiers

PMID24919462
PMCPMC4065310
OpenAlexW2154506633

What OpenQuestion holds

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LicenceCC BY
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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.