A phase I study of inotuzumab ozogamicin as a single agent in pediatric patients in Japan with relapsed/refractory CD22-positive acute lymphoblastic leukemia (INO-Ped-ALL-1).
Acute lymphoblastic leukemia
CD22
Children
Inotuzumab ozogamicin
Relapse/refractory
Journal
International journal of hematology
ISSN: 1865-3774
Titre abrégé: Int J Hematol
Pays: Japan
ID NLM: 9111627
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
14
02
2022
accepted:
10
05
2022
revised:
09
05
2022
pubmed:
1
6
2022
medline:
30
9
2022
entrez:
31
5
2022
Statut:
ppublish
Résumé
Inotuzumab ozogamicin (InO) is a CD22-directed antibody conjugated with calicheamicin approved for adult relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL). This phase 1 study primarily aimed to determine the pediatric recommended doses of InO through the standard 3 + 3 design, and to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity and efficacy of InO. Dose level 1 (DL1) was 1.8 mg/m
Identifiants
pubmed: 35635686
doi: 10.1007/s12185-022-03388-8
pii: 10.1007/s12185-022-03388-8
doi:
Substances chimiques
CD22 protein, human
0
Calicheamicins
0
Sialic Acid Binding Ig-like Lectin 2
0
Aspartate Aminotransferases
EC 2.6.1.1
Alanine Transaminase
EC 2.6.1.2
Inotuzumab Ozogamicin
P93RUU11P7
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
612-621Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2022. Japanese Society of Hematology.
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