دورية أكاديمية
Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
| العنوان: | Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia |
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| المؤلفون: | Kreitman, Robert, Dearden, Claire, Zinzani, Pier Luigi, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas, Le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjørn Tore, Gobbi, Marco, Hellmann, Andrzej, Leprêtre, Stéphane, Maloisel, Frédéric, Ravandi, Farhad, Rousselot, Philipp, Rummel, Mathias, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia Arana, Saglio, Giuseppe, Roboz, Gail, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, Giles, Francis |
| المساهمون: | National Cancer Institute Bethesda (NCI-NIH), National Institutes of Health Bethesda, MD, USA (NIH), Royal Marsden NHS Foundation Trust, Alma Mater Studiorum Università di Bologna = University of Bologna (UNIBO), Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), Service d’Hématologie Centre Hospitalier Lyon Sud - HCL, Centre Hospitalier Lyon Sud CHU - HCL (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Medical University of Łódź (MUL), Johns Hopkins University (JHU), Charité - UniversitätsMedizin = Charité - University Hospital Berlin, Universität Heidelberg Heidelberg = Heidelberg University, Clinical Center of Serbia (KCS), University of Alberta, Universiteit Gent = Ghent University (UGENT), David Geffen School of Medicine Los Angeles, University of California Los Angeles (UCLA), University of California (UC)-University of California (UC), University of Miami Coral Gables, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Università degli Studi di Siena = University of Siena (UNISI), CHU Bordeaux, Ziekenhuis Netwerk Antwerpen (ZNA), Università degli Studi di Milano = University of Milan (UNIMI), Feinberg School of Medicine, Northwestern University Evanston, Faculty of Science Brno (SCI / MUNI), Masaryk University Brno (MUNI), Haukeland University Hospital, University of Bergen (UiB), Ospedale Policlinico San Martino Genoa, Medical University of Gdańsk, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Clinique Sainte Anne Strasbourg, MD Anderson Cancer Center Houston, The University of Texas Health Science Center at Houston (UTHealth), Infection et inflammation (2I), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Justus-Liebig-Universität Gießen = Justus Liebig University (JLU), City of Hope National Medical Center, Bnai Zion Medical Center Israël, Hôpital Côte de Nacre CHU Caen, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), The University of New Mexico Albuquerque, Università degli studi di Torino = University of Turin (UNITO), New York Presbyterian Hospital, MedImmune |
| المصدر: | ISSN: 0887-6924. |
| بيانات النشر: | HAL CCSD Springer Nature |
| سنة النشر: | 2018 |
| المجموعة: | Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQ |
| مصطلحات موضوعية: | [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology |
| الوصف: | International audience ; 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | hal-02194148; https://normandie-univ.hal.science/hal-02194148Test; https://normandie-univ.hal.science/hal-02194148/documentTest; https://normandie-univ.hal.science/hal-02194148/file/s41375-018-0210-1.pdfTest |
| DOI: | 10.1038/s41375-018-0210-1 |
| الإتاحة: | https://doi.org/10.1038/s41375-018-0210-1Test https://normandie-univ.hal.science/hal-02194148Test https://normandie-univ.hal.science/hal-02194148/documentTest https://normandie-univ.hal.science/hal-02194148/file/s41375-018-0210-1.pdfTest |
| حقوق: | http://creativecommons.org/licenses/byTest/ ; info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.3E70F126 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1038/s41375-018-0210-1 |
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