dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Timmerman, John |
dc.contributor.author | Herbaux, Charles |
dc.contributor.author | Ribrag, Vincent |
dc.contributor.author | Zelenetz, Andrew D. |
dc.contributor.author | Houot, Roch |
dc.contributor.author | Neelapu, Sattva S. |
dc.contributor.author | Carpio Segura, Cecilia Carmen |
dc.date.accessioned | 2021-11-10T11:24:55Z |
dc.date.available | 2021-11-10T11:24:55Z |
dc.date.issued | 2020-05 |
dc.identifier.citation | Timmerman J, Herbaux C, Ribrag V, Zelenetz AD, Houot R, Neelapu SS, et al. Urelumab alone or in combination with rituximab in patients with relapsed or refractory B-cell lymphoma. Am J Hematol. 2020 May;95:510–20. |
dc.identifier.issn | 1096-8652 |
dc.identifier.uri | https://hdl.handle.net/11351/6523 |
dc.description | B-cell lymphoma; Urelumab |
dc.description.abstract | Urelumab, a fully human, non-ligand binding, CD137 agonist IgG4 monoclonal antibody, enhances T-cell and natural killer-cell antitumor activity in preclinical models, and may enhance cytotoxic activity of rituximab. Here we report results in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and other B-cell lymphomas, in phase 1 studies evaluating urelumab alone (NCT01471210) or combined with rituximab (NCT01775631). Sixty patients received urelumab (0.3 mg/kg IV Q3W, 8 mg IV Q3W, or 8 mg IV Q6W); 46 received urelumab (0.1 mg/kg, 0.3 mg/kg, or 8 mg IV Q3W) plus rituximab 375 mg/m2 IV QW. The maximum tolerated dose (MTD) of urelumab was determined to be 0.1 mg/kg or 8 mg Q3W after a single event of potential drug-induced liver injury occurred with urelumab 0.3 mg/kg. Treatment-related AEs were reported in 52% (urelumab: grade 3/4, 15%) and 72% (urelumab + rituximab: grade 3/4, 28%); three led to discontinuation (grade 3 increased AST, grade 4 acute hepatitis [urelumab]; one death from sepsis syndrome [urelumab plus rituximab]). Objective response rates/disease control rates were 6%/19% (DLBCL, n = 31), 12%/35% (FL, n = 17), and 17%/42% (other B-cell lymphomas, n = 12) with urelumab and 10%/24% (DLBCL, n = 29) and 35%/71% (FL, n = 17) with urelumab plus rituximab. Durable remissions in heavily pretreated patients were achieved; however, many were observed at doses exceeding the MTD. These data show that urelumab alone or in combination with rituximab demonstrated manageable safety in B-cell lymphoma, but the combination did not enhance clinical activity relative to rituximab alone or other current standard of care. |
dc.language.iso | eng |
dc.publisher | Wiley |
dc.relation.ispartofseries | American Journal of Hematology;95 |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Cèl·lules B - Tumors - Tractament |
dc.subject | Medicaments antineoplàstics - Ús terapèutic |
dc.subject.mesh | Lymphoma, Large B-Cell, Diffuse |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.subject.mesh | /therapeutic use |
dc.title | Urelumab alone or in combination with rituximab in patients with relapsed or refractory B-cell lymphoma |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1002/ajh.25757 |
dc.subject.decs | linfoma de células B grandes difuso |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.subject.decs | /uso terapéutico |
dc.relation.publishversion | https://doi.org/10.1002/ajh.25757 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Timmerman J] UCLA Medical Center, Los Angeles, California. [Herbaux C] Centre Hospitalier Régional Universitaire de Lille, Lille, France. [Ribrag V] Institut Gustave Roussy, Villejuif, France. [Zelenetz AD] Memorial Sloan Kettering Cancer Center, New York, New York. [Houot R] CHU Rennes, Service Hématologie Clinique, Rennes, France. INSERM, Unité dʼInvestigation Clinique, Rennes, France. [Neelapu SS] The University of Texas MD Anderson Cancer Center, Houston, Texas. [Carpio C] Vall dʼHebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain |
dc.identifier.pmid | 32052473 |
dc.identifier.wos | 000516991200001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |