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Autor
Ammerlaan, Anneke J C 1 Bautista Sirvent, Francisco J 1 Bertrand, Yves 1 Beverloo, H Berna 1 Bielorai, Bella 1 Boer, Judith M 1 Brivio, Erica 1 Bruno, Benedicte 1 Chen, Ying 1 Chen-Santel, Christiane 1 Engstler, Gernot 1 Jiang, Yilin 1 Locatelli, Franco 1 Michels, Naomi 1 Pennesi, Edoardo 1 Petit, Arnaud 1 Plat, Geneviève 1 Reinhardt, Dirk 1 Rialland, Fanny 1 Rives, Susana 1
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Pracoviště
Department of Clinical Genetics Erasm... 1 Department of Hematology Oncology and... 1 Department of Immunology Erasmus MC U... 1 Department of Pediatric Hematology an... 1 Department of Pediatric Oncology Eras... 1 Department of Pediatric Oncology Esse... 1 Department of Pediatric Oncology and ... 1 Department of Pediatrics Division of ... 1 Department of Pediatrics Rostock Univ... 1 Department of pediatric Hematology an... 1 Division of Pediatric Hematology and ... 1 Institut de Recerca Sant Joan de Déu ... 1 Institute of Pediatric Hematology and... 1 IntReALL study group Berlin Germany 1 Oncode Institute Utrecht the Netherlands 1 Pediatric Hematology Hôpital Jeanne d... 1 Pediatric Hematology Oncology Unit De... 1 Pediatric Hematology and Oncology Uni... 1 Pediatric Oncology and Hematology Dep... 1 Pfizer Inc Groton CT USA 1
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Autor
Ammerlaan, Anneke J C 1 Bautista Sirvent, Francisco J 1 Bertrand, Yves 1 Beverloo, H Berna 1 Bielorai, Bella 1 Boer, Judith M 1 Brivio, Erica 1 Bruno, Benedicte 1 Chen, Ying 1 Chen-Santel, Christiane 1 Engstler, Gernot 1 Jiang, Yilin 1 Locatelli, Franco 1 Michels, Naomi 1 Pennesi, Edoardo 1 Petit, Arnaud 1 Plat, Geneviève 1 Reinhardt, Dirk 1 Rialland, Fanny 1 Rives, Susana 1
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Pracoviště
Department of Clinical Genetics Erasm... 1 Department of Hematology Oncology and... 1 Department of Immunology Erasmus MC U... 1 Department of Pediatric Hematology an... 1 Department of Pediatric Oncology Eras... 1 Department of Pediatric Oncology Esse... 1 Department of Pediatric Oncology and ... 1 Department of Pediatrics Division of ... 1 Department of Pediatrics Rostock Univ... 1 Department of pediatric Hematology an... 1 Division of Pediatric Hematology and ... 1 Institut de Recerca Sant Joan de Déu ... 1 Institute of Pediatric Hematology and... 1 IntReALL study group Berlin Germany 1 Oncode Institute Utrecht the Netherlands 1 Pediatric Hematology Hôpital Jeanne d... 1 Pediatric Hematology Oncology Unit De... 1 Pediatric Hematology and Oncology Uni... 1 Pediatric Oncology and Hematology Dep... 1 Pfizer Inc Groton CT USA 1
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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
PubMed
35468945
DOI
10.1038/s41375-022-01576-3
Knihovny.cz E-zdroje
Inotuzumab Ozogamicin is a CD22-directed antibody conjugated to calicheamicin, approved in adults with relapsed or refractory (R/R) B cell acute lymphoblastic leukemia (BCP-ALL). Patients aged 1-18 years, with R/R CD22 + BCP-ALL were treated at the RP2D of 1.8 mg/m2. Using a single-stage design, with an overall response rate (ORR) ≤ 30% defined as not promissing and ORR > 55% as expected, 25 patients needed to be recruited to achieve 80% power at 0.05 significance level. Thirty-two patients were enrolled, 28 were treated, 27 were evaluable for response. The estimated ORR was 81.5% (95%CI: 61.9-93.7%), and 81.8% (18/22) of the responding subjects were minimal residual disease (MRD) negative. The study met its primary endpoint. Median follow up of survivors was 16 months (IQR: 14.49-20.07). One year Event Free Survival was 36.7% (95% CI: 22.2-60.4%), and Overall Survival was 55.1% (95% CI: 39.1-77.7%). Eighteen patients received consolidation (with HSCT and/or CAR T-cells therapy). Sinusoidal obstructive syndrome (SOS) occurred in seven patients. MRD negativity seemed correlated to calicheamicin sensitivity in vitro, but not to CD22 surface expression, saturation, or internalization. InO was effective in this population. The most relevant risk was the occurrence of SOS, particularly when InO treatment was followed by HSCT.
- MeSH
- akutní lymfatická leukemie * farmakoterapie MeSH
- akutní nemoc MeSH
- dítě MeSH
- doba přežití bez progrese choroby MeSH
- inotuzumab ozogamicin MeSH
- kalicheamiciny * MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
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- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- práce podpořená grantem MeSH
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