Evidence map›Paper›PMID 40758949›Full record

Trial reportBlood advances2025

Brentuximab vedotin addition to gemcitabine in relapsed or refractory peripheral T-cell lymphoma: a LYSA phase 2 study.

Olivier Tournilhac, Kamal Bouabdallah, Solène Lecolant, Maya Hacini, Kamel Laribi, Sébastien Bailly, Thibaut Belmondo, Marie Maerevoet, Loic Ysebaert, Stéphanie Guidez and 33 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03496779 (A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT03496779 phase2completednot on this map

A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance

TypeinterventionalSponsorThe Lymphoma Academic Research OrganisationRan2018 to 2022Enrolled71ConditionsRefractory Peripheral T-Cell Lymphoma, Relapsed Peripheral T-Cell LymphomaArmsBrentuximab Vedotin - induction, Gemcitabine, Brentuximab Vedotin - maintenance, autologous or allogeneic stem cell transplantation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

43 authors.

Olivier TournilhacDepartment of Hematology and Cell Therapy, Clermont-Ferrand University Hospital, Université Clermont, Auvergne, EA7453 Chelter Centre d'Investigation Clinique-1405, Clermont-Ferrand, France.ORCID 0000-0002-9438-621X
Kamal BouabdallahDepartment of Hematology, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.
Solène LecolantDepartment of Immunology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.ORCID 0000-0001-6793-149X
Maya HaciniDepartment of Hematology, Centre Hospitalier Chambery, Chambery, France.
Kamel LaribiDepartment of Hematology, Centre Hospitalier Le Mans, Le Mans, France.
Sébastien BaillyDepartment of Hematology and Cell Therapy, Clermont-Ferrand University Hospital, Université Clermont, Auvergne, EA7453 Chelter Centre d'Investigation Clinique-1405, Clermont-Ferrand, France.
Thibaut BelmondoDepartment of Immunology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.ORCID 0009-0007-1220-726X
Marie MaerevoetDepartment of Hematology, Institut Jules Bordet, Hopital Universitaire de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium.
Loic YsebaertDepartment of Hematology, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France.ORCID 0000-0003-4102-7261
Stéphanie GuidezDepartment of Hematology, Centre Hospitalier Universitaire Poitiers, Poitiers, France.ORCID 0000-0001-8755-5591
Steven Le GouillDepartment of Hematology, Institut Curie, Saint Cloud, Université de Versailles Saint-Quentin, Versailles, France.ORCID 0000-0001-9840-2128
Christophe BonnetDepartment of Hematology, Service d'hématologie, Centre Hospitalier Universitaire de Liège, Liège Université, Liège, Belgium.
Marc AndréDepartment of Hematology, Centre Hospitalier Universitaire Université Catholique de Louvain, Namur, Belgium.ORCID 0000-0001-7101-810X
Jehan DupuisDepartment of Hematology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.
Catherine ThieblemontDepartment of Hematology and Oncology, Centre Hospitalier Universitaire Saint Louis, Paris, France.
Emmanuel BachyDepartment of Hematology, Centre Hospitalier Universitaire Lyon, Lyon, France.ORCID 0000-0003-2694-7510
Nicolas DaguindauDepartment of Hematology, Centre Hospitalier Annecy, Annecy, France.
Franck MorschhauserDepartment of Hematology, Centre Hospitalier Universitaire Lille, Lille, France.ORCID 0000-0002-3714-9824
Sabine TricotCentre Hospitalier Valenciennes, Valenciennes, France.
Charline MoulinDepartment of Hematology, University Hospital of Nancy, Nancy, France.ORCID 0000-0003-3696-0655
Anne BanosDepartment of Hematology, Centre Hospitalier Universitaire Bayonne, Bayonne, France.
Roch HouotDepartment of Hematology, Centre Hospitalier Universitaire Rennes, Rennes, France.ORCID 0000-0003-1729-8213
Adrien ChauchetDepartment of Hematology, Centre Hospitalier Universitaire Besançon, Besançon, France.
Emmanuel GyanDepartment of Hematology, Centre Hospitalier Universitaire Tours, Tours, France.ORCID 0000-0002-7651-9189
Guillaume CartronDepartment of Hematology, Centre Hospitalier Universitaire Montpellier, Montpellier, France.ORCID 0000-0003-0659-9635
Hassan FarhatDepartment of Hematology, Centre Hospitalier Universitaire Versailles, Versailles, France.
Vincent CamusDepartment of Hematology, Centre Henri Becquerel, Rouen, France.ORCID 0000-0002-1559-007X
Bernard DrenouDepartment of Hematology, Centre Hospitalier Universitaire Mulhouse, Mulhouse, France.
Hacene ZerazhiDepartment of Hematology, Centre Hospitalier Avignon, Avignon, France.
David SibonDepartment of Hematology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.ORCID 0000-0002-9205-625X
Emmanuelle Nicolas-VirelizierDepartment of Hematology, Centre Régional de Lutte Contre le Cancer Lyon, Lyon, France.
Caroline DeletteDepartment of Hematology, Centre Hospitalier Universitaire Amiens, Amiens, France.
Sylvia SnauwaertDepartment of Hematology, Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium.
Sarah BaillyDepartment of Hematology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Richard DelarueDepartment of Hematology, Centre Hospitalier Universitaire Necker, Paris, France.
Sylvain CarrasDepartment of Hematology, Centre Hospitalier Universitaire Grenoble, Grenoble, France.ORCID 0000-0002-0796-7914
Albane Ledoux-PilonDepartment of Hematology and Cell Therapy, Clermont-Ferrand University Hospital, Université Clermont, Auvergne, EA7453 Chelter Centre d'Investigation Clinique-1405, Clermont-Ferrand, France.
Marie-Cécile ParrensDepartment of Hematology, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.ORCID 0000-0002-4335-4138
Samuel GrioletDepartment of Statistics, Lymphoma Study Association Recherche Clinique Lyon, Lyon, France.
Philippe GaulardDepartment of Pathology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.ORCID 0000-0002-4243-905X
Marie-Hélène Delfau-LarueDepartment of Immunology, Centre Hospitalier Universitaire Créteil, University Hospital Henri Mondor, University Paris-Est Créteil and INSERM U955, Créteil, France.ORCID 0000-0002-8010-2343
Laurence de LevalDepartment of Laboratory Medicine and Pathology, University Hospital and Lausanne University, Lausanne, Switzerland.ORCID 0000-0003-3994-516X
Gandhi Laurent DamajDepartment of Hematology, Haematology Institute and University of Caen, CRNS, ISTCT UMR6030, GIP Cyceron, Caen, France.ORCID 0000-0002-4689-3882

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractWe aim to evaluate the efficacy of brentuximab vedotin (BV) combined with gemcitabine (GBV) followed by BV maintenance in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). Patients with at least 5% CD30+ cells by immunohistochemistry received 4 GBV induction (28 days) cycles of gemcitabine 1000 mg/m2 (day 1, day 15) plus BV 1.8 mg/kg (day 8) followed, in responding patients, by up to 12 BV maintenance (21 day) cycles. Primary end point was overall response rate (ORR) after 4 induction cycles by computed tomography scan-based Lugano criteria. Of 71 enrolled patients (median age of 66 years), 80.3% had received 1 previous line and 60.6% were refractory. The diagnoses per pathology central review were follicular helper T-cell lymphomas (TFHL; 47.9%), anaplastic large-cell lymphomas (ALCL; anaplastic lymphoma kinase [ALK] negative [19.7%] and ALK+ [7%]), peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS; 12.7%), and other entities (12.7%). In the intention-to-treat analysis, ORR was 46.5%, with 19.7% complete response. Twenty-eight patients received maintenance. Grade 3 to 4 adverse events reported in ≥10% of patients during induction comprised neutropenia (55%), thrombocytopenia (14%), anemia (21%), and infection (14%); during maintenance comprised neutropenia (39%), thrombocytopenia (21%), and peripheral neuropathy (14%). With a median follow-up of 32.6 months, the median duration of response, progression-free, and overall survival were 15.8, 4.5, and 12.9 months, respectively. Efficacy, higher in ALCL, was present in the TFHL and PTCL-NOS group. A negative association of high baseline soluble CD30 on both response and survival was found, which, in ad hoc analysis, appeared highly relevant in patients with TFHL and PTCL-NOS. This trial was registered at the European Union Drug Regulating Authorities Clinical Trials database as #2017-000409-1, and at www.clinicaltrials.gov as #NCT03496779.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBrentuximab VedotinDeoxycytidineLymphoma, T-Cell, PeripheralAdultAgedAged, 80 and overFemaleGemcitabineHumansMaleMiddle AgedRecurrenceTreatment OutcomeBrentuximab VedotinDeoxycytidineGemcitabine

Identifiers

PMID40758949
PMCPMC12744279

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.