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dc.contributor.authorHamadani, M.
dc.contributor.authorCollins, G. P.
dc.contributor.authorCaimi, P. F.
dc.contributor.authorSamaniego, F.
dc.contributor.authorSpira, A.
dc.contributor.authorDavies, A.
dc.contributor.authorRadford, John A
dc.contributor.authorMenne, T.
dc.contributor.authorKarnad, A.
dc.contributor.authorZain, J. M.
dc.contributor.authorFields, P.
dc.contributor.authorHavenith, K.
dc.contributor.authorCruz, H. G.
dc.contributor.authorHe, S.
dc.contributor.authorBoni, J.
dc.contributor.authorFeingold, J.
dc.contributor.authorWuerthner, J
dc.contributor.authorHorwitz, S.
dc.date.accessioned2021-07-19T10:28:49Z
dc.date.available2021-07-19T10:28:49Z
dc.date.issued2021en
dc.identifier.citationHamadani M, Collins GP, Caimi PF, Samaniego F, Spira A, Davies A, et al. Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study. The Lancet Haematology. 2021 Jun;8(6):e433–45.en
dc.identifier.pmid34048682en
dc.identifier.doi10.1016/s2352-3026(21)00103-4en
dc.identifier.urihttp://hdl.handle.net/10541/624106
dc.description.abstractBackground: Novel approaches are required to improve outcomes in relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. We aimed to evaluate camidanlumab tesirine, an anti-CD25 antibody-drug conjugate, in this patient population. Methods: This was a phase 1, dose-escalation (part 1), dose-expansion (part 2), multicentre trial done in 12 hospital sites (seven in the USA and five in the UK). Adults (≥18 years old) with pathologically confirmed relapsed or refractory classical Hodgkin lymphoma or non-Hodgkin lymphoma, an Eastern Cooperative Oncology Group performance status 0-2, who had no therapies available to them with established clinical benefit for their disease stage were enrolled. Camidanlumab tesirine was administered intravenously (3-150 μg/kg) once every 3 weeks. Primary objectives were to assess dose-limiting toxicity, determine maximum tolerated dose and recommended expansion dose(s), and assess safety of camidanlumab tesirine. Safety was assessed in all treated patients; antitumour activity was assessed in patients with one or more valid baseline and post-baseline disease assessment and in those who had disease progression or died after first study-drug dose. This trial was registered with ClinicalTrials.gov, NCT02432235. Findings: Between Oct 5, 2015, and Jun 30, 2019, 133 patients were enrolled (77 [58%] had classical Hodgkin lymphoma and 56 (42%) had non-Hodgkin lymphoma). Median follow-up was 9·2 months (IQR 4·2-14·3). Eight dose-limiting toxicities were reported in five (6%) of 86 patients who were evaluable; the maximum tolerated dose was not reached. The recommended doses for expansion were 30 μg/kg and 45 μg/kg for patients with classical Hodgkin lymphoma and 80 μg/kg for patients with T-cell non-Hodgkin lymphomas. No recommended doses for expansion were defined for B-cell non-Hodgkin lymphomas. Grade 3 or worse treatment-emergent adverse events (reported by ≥10% of the 133 patients) included increased γ-glutamyltransferase (20 [15%] patients), maculopapular rash (16 [12%]), and anaemia (15 [11%]); 74 (56%) patients had serious treatment-emergent adverse events, most commonly pyrexia (16 [12%]). One (1%) fatal treatment-emergent adverse event and two (2%) deaths outside the reporting period were considered at least possibly study-drug related. Antitumoural activity was seen in classical Hodgkin and non-Hodgkin lymphomas; notably in all patients with classical Hodgkin lymphoma, the overall response was 71% (95% CI 60-81). Interpretation: These results warrant evaluation of camidanlumab tesirine as a potential treatment option for relapsed or refractory lymphoma, particularly in patients with classical Hodgkin lymphomaen
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/s2352-3026(21)00103-4en
dc.titleCamidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion studyen
dc.typeArticleen
dc.contributor.departmentDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.en
dc.identifier.journalLancet Haematologyen
dc.description.noteen]


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