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English to Spanish: BTmab and Neurological Events in Patients with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia General field: Medical
Source text - English BTmab and Neurological Events in Patients with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia
XXX recommends the use of its products only in accordance with the approved local product label1
Neurological events associated with BTmab are thought to be caused by an inflammatory irritation of the neuroendothelium through BTmab-activated T cells that locally release neurotoxic cytokines and chemokines en route to the CNS. The variability of CD19 expression in the brain suggests a potential explanation for neurotoxicity in a subset of patients, since patients with a certain pattern of CD19 expression in neurons may be susceptible to a neuroinflammatory response from CD19-engaging T cells. Further analyses of the causes of CNS AEs, using pretreatment magnetic resonance imaging scans and spinal fluid analysis, are still pending.
PHASE 2 EXPLORATORY STUDY
An open-label, single-arm, multicenter, exploratory, phase 2 study evaluated the use of BTmab in adult patients (N = 36) with relapsed or refractory ALL. The primary endpoint was the proportion of patients who achieved a hematologic complete remission (CR) or a CR with partial hematologic recovery (CRh; defined as platelets > 50,000/mcL, hemoglobin > 7 g/dL, and absolute neutrophil count > 500/mcL) within the first two treatment cycles. Patients with a history or presence of clinically relevant CNS pathology and active CNS leukemia were excluded from study entry.
Translation - Spanish BTmab y acontecimientos neurológicos en pacientes con leucemia linfoblástica aguda de precursores de los linfocitos B recidivante o resistente al tratamiento
XXX recomienda que sus productos solamente se usen conforme a la ficha técnica del producto aprobada en cada país.
Se cree que los acontecimientos relacionados con el BTmab se pueden deber a una irritación inflamatoria del neuroendotelio causada por los linfocitos T activados por el BTmab, que liberan en el lugar citocinas y quimiocinas neurotóxicas en la vía al SNC. La variabilidad de la expresión de CD19 en el cerebro sugiere una explicación posible para la neurotoxicidad en un subgrupo de pacientes, dado que los pacientes que tienen un patrón determinado de expresión de CD19 en las neuronas pueden ser propensos a tener una respuesta neuroinflamatoria provocada por los linfocitos T que se unen a CD19. Aún quedan pendientes nuevos análisis de la causas de AA del SNC, mediante exploraciones por resonancia magnética y análisis del líquido cefalorraquídeo antes del tratamiento.
ESTUDIO EXPLORATORIO EN FASE II
Un estudio exploratorio en fase II, multicéntrico, con un solo grupo, sin enmascaramiento, evaluó el uso del BTmab en pacientes adultos (N=36) con LLA recidivante o resistente al tratamiento. El criterio principal de valoración fue la proporción de pacientes que logró la remisión hematológica completa (RC) o la RC con recuperación hematológica parcial (RCh; que se define en función de lo siguiente: plaquetas >50,000/µl, hemoglobina >7 g/dl, y recuento absoluto de neutrófilos >500/µl) durante los dos primeros ciclos de tratamiento. Se excluyó del estudio a pacientes que tuvieran antecedentes o presentaran características anatomopatológicas del SNC importantes desde el punto de vista clínico y leucemia aguda con afectación del SNC.
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English to Spanish (American Translators Association, verified) English to Spanish (Cambridge University (ESOL Examinations), verified) English to Spanish (Universidad de la República (Facultad de Derecho)) Italian to Spanish (Università per Stranieri di Perugia)
IamagraduatedbiologistandATA-certifiedEnglish-Spanishtranslator,specializedinlifesciences,medicine,biomedicalsciences,microbiologyandpharmaceuticals,withover23yearsofexperience.Iampassionateabouttranslating,andIlovetojoinmyknowledgeandexpertiseasabiologistwithmyworkasatranslatorinallthefieldsofmedicineandlifesciences.Itranslateallkindsofdocumentsinthese areas.Someexamplesincludeclinicaltrials,clinicalresearch,diseasemanagement,oncology,pharmacology, among others.IamalsotheSpanishtranslatoroftheFinnishwebsiteNatureGate®http://www.luontoportti.com/suomi/es/.
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