Phase I study of alvocidib plus cytarabine/mitoxantrone or cytarabine/daunorubicin for acute myeloid leukemia in Japan.


Journal

Cancer science
ISSN: 1349-7006
Titre abrégé: Cancer Sci
Pays: England
ID NLM: 101168776

Informations de publication

Date de publication:
Dec 2022
Historique:
revised: 27 05 2022
received: 04 01 2022
accepted: 06 06 2022
pubmed: 12 6 2022
medline: 15 12 2022
entrez: 11 6 2022
Statut: ppublish

Résumé

Therapeutic improvements are needed for patients with acute myeloid leukemia (AML), particularly those who have relapsed or who have treatment-refractory (R/R) AML or newly diagnosed patients with poor prognostic factors. Alvocidib (DSP-2033), a potent cyclin-dependent kinase 9 inhibitor, has previously demonstrated promising clinical activity for the treatment of AML. In this multicenter, open-label, uncontrolled, 3 + 3 phase I study, we investigated the safety and tolerability of alvocidib administered in combination with either cytarabine and mitoxantrone (ACM) for R/R AML or cytarabine/daunorubicin (A + 7 + 3) for newly diagnosed AML. Alvocidib was administered to all patients as a 30-min intravenous (i.v.) bolus (30 mg/m

Identifiants

pubmed: 35689544
doi: 10.1111/cas.15458
pmc: PMC9746059
doi:

Substances chimiques

Cytarabine 04079A1RDZ
Daunorubicin ZS7284E0ZP

Banques de données

ClinicalTrials.gov
['NCT03563560']

Types de publication

Multicenter Study Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

4258-4266

Subventions

Organisme : Sumitomo Pharma

Informations de copyright

© 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

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Auteurs

Takayuki Ikezoe (T)

Department of Hematology, Fukushima Medical University Hospital, Fukushima, Japan.

Kiyoshi Ando (K)

Department of Hematology and Oncology, Tokai University, Tokyo, Japan.

Masahiro Onozawa (M)

Department of Hematology, Hokkaido University Hospital, Sapporo, Japan.

Takahisa Yamane (T)

Department of Hematology, Osaka City General Hospital, Osaka, Japan.

Naoko Hosono (N)

Department of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan.

Yasuyoshi Morita (Y)

Department of Hematology and Rheumatology, Kindai University Hospital, Osaka-Sayama, Japan.

Toru Kiguchi (T)

Department of Hematology, Chugoku Central Hospital, Fukuyama, Japan.

Hiromi Iwasaki (H)

Department of Hematology, National Hospital Organization, Kyushu Medical Center, Fukuoka, Japan.

Toshihiro Miyamoto (T)

Department of Medicine and Biosystemic Science Faculty of Medicine, Kyushu University, Fukuoka, Japan.

Keisuke Matsubara (K)

Sumitomo Pharma Co., Ltd., Tokyo, Japan.

Saori Sugimoto (S)

Sumitomo Pharma Co., Ltd., Tokyo, Japan.

Yasushi Miyazaki (Y)

Department of Hematology, Atomic Bomb Disease and Hibakusha Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.

Masahiro Kizaki (M)

Department of Hematology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.

Koichi Akashi (K)

Department of Medicine and Biosystemic Science Faculty of Medicine, Kyushu University, Fukuoka, Japan.

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Classifications MeSH