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Phase 1/2 Study of Brentuximab Vedotin in Pediatric Pts with Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) or Systemic Anaplastic Large-Cell Lymphoma (sALCL): Preliminary Phase…

F Locatelli, K Neville, A Rosolen, J Landman-Parker, N Aladjidi, A Beishuizen, S Daw, L Gore, ARK Franklin, A Fasanmade, J Wang, J Sachs, C Mauz-Körholz · Klinische Pädiatrie · 2014 · Heft 03

Dokument
1200266
CareLit-ID
Jahr
2014
Publikation
PDF
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Metadaten
DOI
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Bibliografische Angaben

Zeitschrift
Klinische Pädiatrie
Autor:innen
F Locatelli, K Neville, A Rosolen, J Landman-Parker, N Aladjidi, A Beishuizen, S Daw, L Gore, ARK Franklin, A Fasanmade, J Wang, J Sachs, C Mauz-Körholz
Ausgabe
Heft 03 / 2014
Seiten
–
Erschienen: 2014-03-31 00:00:00
ISSN
0300-8630
DOI
10.1055/s-0034-1371149

Zusammenfassung

Question: To evaluate the safety and efficacy of brentuximab vedotin, a CD30-targeted antibody-drug conjugate, in pediatric pts with R/R HL or sALCL (currently approved in the USA and EU for use in adults with R/R HL or sALCL). We report initial phase 2 response, safety and pharmacokinetics (PK) data in R/R HL pts at the RP2D of 1.8 mg/kg Q3wk. Methods: This ongoing phase 1/2 prospective, open-label, multicenter study is the first brentuximab vedotin clinical trial conducted exclusively in pediatric pts (NCT01492088). The phase 2 primary objective is ORR (CR + PR) at the RP2D; secondary objectives include TTP, T…

Schlagworte

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