A phase 1b study of blinatumomab in Japanese children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.


Journal

International journal of hematology
ISSN: 1865-3774
Titre abrégé: Int J Hematol
Pays: Japan
ID NLM: 9111627

Informations de publication

Date de publication:
Aug 2020
Historique:
received: 13 08 2019
accepted: 29 05 2020
revised: 10 05 2020
pubmed: 22 6 2020
medline: 30 10 2020
entrez: 22 6 2020
Statut: ppublish

Résumé

Novel therapies are needed for children with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is a bispecific T-cell engager immunotherapy that simultaneously binds to CD3-positive cytotoxic T cells and CD19-positive B cells and redirects the patient's T cells to lyse malignant and normal B cells. We conducted an open-label phase 1b study to determine the safety, pharmacokinetics, efficacy, and recommended dose of blinatumomab in Japanese children with R/R B-cell precursor ALL. Patients received induction blinatumomab for 4 weeks (5 μg/m

Identifiants

pubmed: 32564243
doi: 10.1007/s12185-020-02907-9
pii: 10.1007/s12185-020-02907-9
doi:

Substances chimiques

Antibodies, Bispecific 0
Antineoplastic Agents 0
blinatumomab 4FR53SIF3A

Types de publication

Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

223-233

Auteurs

Keizo Horibe (K)

Department of Pediatrics, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan. keizo.horibe@nnh.go.jp.

Joan D Morris (JD)

Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.

Catherine A Tuglus (CA)

Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.

Cedric Dos Santos (C)

Clinical Biomarkers, Amgen Inc., South San Francisco, CA, USA.

James Kalabus (J)

Clinical Pharmacology, Amgen Inc., South San Francisco, CA, USA.

Abraham Anderson (A)

Clinical Biomarkers, Amgen Inc., Thousand Oaks, CA, USA.

Hiroaki Goto (H)

Division of Hematology/Oncology, Kanagawa Children's Medical Center, Yokohama, Kanagawa, Japan.

Chitose Ogawa (C)

Department of Pediatric Oncology, National Cancer Center Hospital, Chūō, Tokyo, Japan.

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Classifications MeSH