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

We 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.

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Publication Details

Journal
Blood Advances
Published
2025-08-04
DOI
https://doi.org/10.1182/bloodadvances.2024015787
Citations
1
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
1.47

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article

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

Sabine Tricot, Jehan Dupuis, H. Farhat, Solene Lecolant et al.
1 citations
Blood Advances
Lymphoma Diagnosis and Treatment
1.47
article

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

Sabine Tricot, Jehan Dupuis, H. Farhat, Solene Lecolant, Sébastien Bailly, Thibaut Belmondo, Philippe Gaulard, Christophe Bonnet, Steven Le Gouill, Marie Maerevoet, Adrien Chauchet, Roch Houot, Guillaume Cartron, Catherine Thiéblemont, Kamel Laribi, Albane Ledoux‐Pilon, Caroline Delette, Charline Moulin, Stéphanie Guidez, Sarah Bailly, Franck Morschhauser, Olivier Tournilhac, Emmanuel Bachy, Richard Delarue, Marie Parrens, Gandhi Laurent Damaj, Maya Hacini, Krimo Bouabdallah, Bernard Drénou, Vincent Camus, Marie‐Hélène Delfau‐Larue, Laurence de Leval, Sylvain Carras, Marc André, Emmanuel Gyan, Hacène Zerazhi, Sylvia Snauwaert, Nicolas Daguindau, David Sibon, Loïc Ysebaert, Samuel Griolet, Emmanuelle Nicolas Virelizier, Anne Banos
article en
1 citations

Abstract

We 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.

Blood AdvancesVol. 9(24)
Université Claude Bernard Lyon 1 (FR), Hôpital Necker-Enfants Malades (FR), Cliniques Universitaires Saint-Luc (BE), Université Libre de Bruxelles (BE), Université de Bordeaux (FR), Inserm (FR), Université de Versailles Saint-Quentin-en-Yvelines (FR), Université Paris-Est Créteil (FR), Université de Lille (FR), Centre Hospitalier Universitaire de Grenoble (FR), Institut Jules Bordet (BE), Centre Hospitalier Universitaire de Bordeaux (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire Henri-Mondor (FR), Centre Hospitalier Universitaire de Toulouse (FR), Centre Hospitalier Universitaire de Besançon (FR), Centre Hospitalier Universitaire de Montpellier (FR), CHU Dinant Godinne UCL Namur (BE), Centre Hospitalier Universitaire de Tours (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Assistance Publique – Hôpitaux de Paris (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospices Civils de Lyon (FR), University of Clermont Auvergne (FR), Centre Léon Bérard (FR), The Lymphoma Academic Research Organisation (FR), Centre Hospitalier Métropole Savoie (FR), Centre Hospitalier Universitaire de Poitiers (FR), Hôpital Lyon Sud (FR), Centre Hospitalier de Mulhouse (FR), Laboratoire Informatique d'Avignon (FR), AZ Sint-Jan (BE), Centre de Recherche en Cancérologie de Lyon (FR), Centre Hospitalier du Mans (FR), Centre Hospitalier de la Côte Basque (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Hôpitaux Universitaires Henri-Mondor (FR), Centre Hospitalier Annecy Genevois (FR), Centre Hospitalier Universitaire de Liège (BE), Laboratoire National Henri Becquerel (FR), Clermont Université (FR), Hôpital Saint-Louis (FR), Lymphoma Study Association (FR), Laboratoire de Génétique Cellulaire (FR), Cyceron (FR), Centre Hospitalier Universitaire de Rennes (FR), Centre Hospitalier de Valenciennes (FR), Centre Hospitalier de Versailles (FR), Centre Henri Becquerel, Institut Curie (FR), Université Grenoble Alpes (FR), UCLouvain (BE), University of Lausanne (CH), Université de Caen Normandie (FR)
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Good health and well-being
Openalex Percentile: Top 17%
Lymphoma Diagnosis and Treatment
1.47
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