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Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
RJ. Kreitman, C. Dearden, PL. Zinzani, J. Delgado, L. Karlin, T. Robak, DE. Gladstone, P. le Coutre, S. Dietrich, M. Gotic, L. Larratt, F. Offner, G. Schiller, R. Swords, L. Bacon, M. Bocchia, K. Bouabdallah, DA. Breems, A. Cortelezzi, S. Dinner,...
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, Research Support, N.I.H., Intramural, práce podpořená grantem
NLK
ProQuest Central
od 2000-01-01 do Před 1 rokem
Open Access Digital Library
od 1997-01-01
Nursing & Allied Health Database (ProQuest)
od 2000-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2000-01-01 do Před 1 rokem
Public Health Database (ProQuest)
od 2000-01-01 do Před 1 rokem
- MeSH
- bakteriální toxiny terapeutické užití MeSH
- chemorezistence účinky léků MeSH
- dospělí MeSH
- exotoxiny terapeutické užití MeSH
- indukce remise MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie patologie MeSH
- míra přežití MeSH
- následné studie MeSH
- prognóza MeSH
- protinádorové látky terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vlasatobuněčná leukemie farmakoterapie patologie MeSH
- záchranná terapie * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Research Support, N.I.H., Intramural MeSH
This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 μg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.
Azienda Ospedaliera Universitaria University of Siena Siena Italy
Bnai Zion Medical Center Haifa Israel
Centre Hospitalier Lyon Sud Pierre bénite France
Charité Universitätsmedizin Berlin Germany
City of Hope National Medical Center Duarte CA USA
Clinic of Hematology Ospedale Policlinico San Martino Genova Italy
Clinical Center of Serbia Belgrade Serbia
David Geffen School of Medicine UCLA Los Angeles CA USA
Department of Hematology and Transplantation Medical University of Gdańsk Gdańsk Poland
Developmental Therapeutics Consortium Chicago IL USA
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico University of Milan Milan Italy
Ghent University Hospital Ghent Belgium
Helse Bergen HF Haukeland University Hospital Bergen Norway
Hospital Clinic Barcelona Spain
Institute of Hematology Seràgnoli University of Bologna Bologna Italy
Johns Hopkins Kimmel Cancer Center Baltimore MD USA
Justus Liebig University Giessen Germany
L'hôpital Côte de Nacre Caen Cedex 9 Caen France
Masaryk University Brno Czech Republic
MD Anderson Cancer Center Houston TX USA
Medical University of Lodz Copernicus Memorial Hospital Lodz Poland
MedImmune South San Francisco CA USA
National Cancer Institute National Institutes of Health Bethesda MD USA
Northwestern Medicine Feinberg School of Medicine Chicago IL USA
Service d'hématologie CHU Bordeaux F 33000 Bordeaux France
SOL Clinique Sainte Anne Strasbourg France
St James's Hospital Dublin Ireland
Sylvester Comprehensive Cancer Center University of Miami Miami FL USA
The Royal Marsden NHS Foundation Trust London UK
Universitätsklinikum Heidelberg Heidelberg Baden Württemberg Germany
University of Alberta Edmonton Alberta Canada
University of New Mexico Albuquerque NM USA
University of Turin Turin Italy
Weill Cornell Medicine The New York Presbyterian Hospital New York NY USA
Citace poskytuje Crossref.org
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