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Blinatumomab after R-CHOP bridging therapy for patients with Richter transformation: a phase 2 multicentre trial.
Guièze, Romain; Ysebaert, Loïc; Roos-Weil, Damien; Fornecker, Luc-Mathieu; Ferrant, Emmanuelle; Molina, Lysiane; Aurran, Thérèse; Clavert, Aline; de Guibert, Sophie; Michallet, Anne-Sophie; Saad, Alain; Drénou, Bernard; Quittet, Philippe; Hivert, Bénédicte; Laribi, Kamel; Gay, Julie; Quinquenel, Anne; Broseus, Julien; Rouille, Valérie; Schwartz, David; Magnin, Benoit; Lazarian, Grégory; Véronèse, Lauren; de Antonio, Marie; Laurent, Camille; Tournilhac, Olivier; Pereira, Bruno; Feugier, Pierre.
Afiliación
  • Guièze R; CHU Clermont-Ferrand, Service de Thérapie Cellulaire et d'Hématologie Clinique, Clermont-Ferrand, France. rguieze@chu-clermontferrand.fr.
  • Ysebaert L; Université Clermont Auvergne, Unité de Recherche 7453 (CHELTER), Clermont-Ferrand, France. rguieze@chu-clermontferrand.fr.
  • Roos-Weil D; Service d'Hématologie, Institut Universitaire du Cancer de Toulouse, 1 Avenue Irene Joliot-Curie, 31059, Toulouse, France.
  • Fornecker LM; Service d'Hématologie Clinique, Hôpital Pitié-Salpêtrière, AP-HP, Sorbonne Université, Paris, France.
  • Ferrant E; Institut de Cancérologie Strasbourg Europe (ICANS) and University of Strasbourg, Strasbourg, France.
  • Molina L; Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d'Hématologie Clinique, Pierre-Bénite, France.
  • Aurran T; University Hospital Grenoble Alpes, Grenoble, France.
  • Clavert A; Institut Paoli-Calmettes, Hématologie, Marseille, France.
  • de Guibert S; Service des Maladies du Sang, CHU Angers, Angers, France.
  • Michallet AS; Service d'Hématologie Clinique, CHU Rennes, Rennes, France.
  • Saad A; Service d'Hématologie, Centre Léon Bérard, Lyon, France.
  • Drénou B; Haematology Department, Hospital Center of Beziers, Beziers, France.
  • Quittet P; Department of Hematology, CH Mulhouse, Mulhouse, France.
  • Hivert B; Département d'Hématologie, CHU Montpellier, Montpellier, France.
  • Laribi K; Hématologie Clinique, Groupement des Hôpitaux de l'Institut Catholique de Lille Hôpital St Vincent de Paul, Lille, France.
  • Gay J; Department of Hematology, Centre Hospitalier Le Mans, Le Mans, France.
  • Quinquenel A; Service d'Hématologie, Centre Hospitalier de la Côte Basque, Bayonne, France.
  • Broseus J; Department of Hematology, University Hospital of Reims, UFR Médecine, Reims, France.
  • Rouille V; CHRU-Nancy, Service d'Hématologie Biologique, Pôle Laboratoires, F54000, Nancy, France.
  • Schwartz D; Inserm UMRS1256 Nutrition-Génétique et Exposition aux Risques Environnementaux (N-GERE), Université de Lorraine, Nancy, France.
  • Magnin B; French Innovative Leukemia Organization, Tours, France.
  • Lazarian G; French Innovative Leukemia Organization, Tours, France.
  • Véronèse L; Department of Radiology, CHU Clermont-Ferrand, Clermont-Ferrand, France.
  • de Antonio M; Laboratoire d'hématologie, HUPSSD, Hôpital Avicenne, Bobigny, France.
  • Laurent C; Université Clermont Auvergne, Unité de Recherche 7453 (CHELTER), Clermont-Ferrand, France.
  • Tournilhac O; Service de Cytogénétique, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
  • Pereira B; Department of Statistics, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
  • Feugier P; Département de Pathologie, Institut Universitaire du Cancer, Centre Hospitalo-Universitaire (CHU) de Toulouse, Toulouse, France.
Nat Commun ; 15(1): 6822, 2024 Aug 09.
Article en En | MEDLINE | ID: mdl-39122717
ABSTRACT
Richter transformation (RT) is an aggressive lymphoma occurring in patients with chronic lymphocytic leukaemia. Here we investigated the anti-CD3/anti-CD19 T-cell-engager blinatumomab after R-CHOP (i.e. rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with untreated RT of diffuse large B-cell lymphoma histology (NCT03931642). In this multicentre phase 2 study, patients without complete response (CR) after two cycles of R-CHOP were eligible to receive an 8-week blinatumomab induction via continuous vein infusion with stepwise dosing until 112 µg/day. The primary endpoint was the CR rate after blinatumomab induction and secondary endpoint included safety, response duration, progression-free and overall survival. Thirty-nine patients started the first cycle of R-CHOP, 25 of whom received blinatumomab. After blinatumomab induction, five (20%) patients achieved CR, four (16%) achieved partial response, and six (24%) were stable. Considering the entire strategy, the overall response rate in the full-analysis-set was 46% (n = 18), with CR in 14 (36%) patients. The most common treatment-emergent adverse events of all grades in the blinatumomab-safety-set included fever (36%), anaemia (24%), and lymphopaenia (24%). Cytokine release syndrome (grade 1/2) was observed in 16% and neurotoxicity in 20% of patients. Blinatumomab demonstrated encouraging anti-tumour activity (the trial met its primary endpoint) and acceptable toxicity in patients with RT.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vincristina / Prednisona / Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Linfoma de Células B Grandes Difuso / Anticuerpos Biespecíficos / Ciclofosfamida / Rituximab Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Commun Asunto de la revista: BIOLOGIA / CIENCIA Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vincristina / Prednisona / Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Linfoma de Células B Grandes Difuso / Anticuerpos Biespecíficos / Ciclofosfamida / Rituximab Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Commun Asunto de la revista: BIOLOGIA / CIENCIA Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido