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Inotuzumab ozogamicin as single agent in pediatric patients with relapsed and refractory acute lymphoblastic leukemia: results from a phase II trial
E. Pennesi, N. Michels, E. Brivio, VHJ. van der Velden, Y. Jiang, A. Thano, AJC. Ammerlaan, JM. Boer, HB. Beverloo, B. Sleight, Y. Chen, B. Vormoor-Bürger, S. Rives, B. Bielorai, C. Rössig, A. Petit, C. Rizzari, G. Engstler, J. Starý, FJ....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, práce podpořená grantem
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
Odkazy
PubMed
35468945
DOI
10.1038/s41375-022-01576-3
Knihovny.cz E-zdroje
- 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
- Check Tag
- 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
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.
Department of Immunology Erasmus MC University Medical Center Rotterdam Rotterdam the Netherlands
Department of Pediatric Hematology and Oncology University Hospital Motol Prague Czech Republic
Department of Pediatric Oncology and Hematology Hospital Niño Jesús Madrid Spain
Department of Pediatric Oncology Erasmus MC Sophia Children's Hospital Rotterdam the Netherlands
Department of Pediatric Oncology Essen University Hospital Essen Germany
Department of Pediatrics Rostock University Medical Centre Rostock Germany
Division of Pediatric Hematology and Oncology Sheba Medical Center Ramat Gan Israel
Institut de Recerca Sant Joan de Déu Barcelona Spain
IntReALL study group Berlin Germany
Oncode Institute Utrecht the Netherlands
Pediatric Hematology and Oncology University Children's Hospital Muenster Münster Germany
Pediatric Hematology Hôpital Jeanne de Flandre CHRU de Lille Lille France
Pediatric Oncology and Hematology Department Hospital Sant Joan de Déu de Barcelona Barcelona Spain
Princess Máxima Center for Pediatric Oncology Utrecht the Netherlands
Service d'Hématologie Immunologie Oncologie Hôpital des Enfants CHU Toulouse Toulouse France
Service Onco Hématologie Pédiatrique Hôpital Mère Enfant Nantes University Hospital Nantes France
St Anna Children's Hospital Medical University of Vienna Vienna Austria
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