Evidence map›Paper›PMID 38532078›Full record

Trial reportInternational journal of hematology2024

A phase 1/2 study of NS-87/CPX-351 (cytarabine and daunorubicin liposome) in Japanese patients with high-risk acute myeloid leukemia.

Kensuke Usuki, Toshihiro Miyamoto, Takuji Yamauchi, Kiyoshi Ando, Yoshiaki Ogawa, Masahiro Onozawa, Takahiro Yamauchi, Hitoshi Kiyoi, Akira Yokota, Takayuki Ikezoe and 14 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 18 institutions in 1 country.

Kensuke UsukiDepartment of Hematology, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo, 141-8625, Japan. kensuke.usuki@gmail.com.ORCID http://orcid.org/0000-0002-1216-4470
Toshihiro MiyamotoDepartment of Hematology, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.
Takuji YamauchiDepartment of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan.
Kiyoshi AndoDepartment of Hematology and Onclogy, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Yoshiaki OgawaDepartment of Hematology and Onclogy, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Masahiro OnozawaDepartment of Hematology, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.
Takahiro YamauchiDepartment of Hematology and Oncology, University of Fukui, Fukui, Japan.
Hitoshi KiyoiDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.
Akira YokotaDepartment of Hematology, Chiba Aoba Municipal Hospital, Chiba, Japan.
Takayuki IkezoeDepartment of Hematology, Fukushima Medical University, Fukushima, Japan.
Yuna KatsuokaDepartment of Hematology, National Hospital Organization Sendai Medical Center, Sendai, Miyagi, Japan.
Satoru TakadaDepartment of Hematology, Saiseikai Maebashi Hospital, Maebashi, Gunma, Japan.
Nobuyuki AotsukaDepartment of Hematology and Oncology, Japanese Red Cross Society Narita Hospital, Narita, Chiba, Japan.
Yasuyoshi MoritaDepartment of Hematology and Rheumatology, Faculty of Medicine, Kindai University, Sayama, Osaka, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Noboru AsadaDepartment of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
Shuichi OtaDepartment of Hematology, Sapporo Hokuyu Hospital, Sapporo, Hokkaido, Japan.
Atsushi DohiClinical Development Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Kensaku MorimotoData Science Depertment, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Shunji ImaiDrug Metabolism and Pharmacokinetics Research Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Umi KishimotoClinical Development Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan.
Yasushi MiyazakiDepartment of Hematology, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.
Study Group for NS-87/CPX-351
Nippon Shinyaku (Japan) · JPUniversity of Fukui · JPChiba Aoba Municipal Hospital · JPHokkaido University Hospital · JPSapporo Hokuyu Hospital · JPFukushima Medical University · JPGunma Saiseikai Maebashi Hospital · JPHiroshima University · JPJapanese Red Cross Narita Hospital · JPKanazawa University · JPKindai University · JPKobe City Medical Center General Hospital · JPNagasaki University · JPNagoya University · JPNTT Medical Center · JPOkayama University Hospital · JPSendai Medical Center · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesNS-87/CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin. NS-87/CPX-351 exerts antileukemic action by maintaining a synergistic molar ratio of cytarabine to daunorubicin of 5:1 within the liposome while in circulation. Patients with high-risk acute myeloid leukemia (AML), which includes therapy-related AML and AML with myelodysplasia-related changes (AML-MRC), have poorer outcomes than those with other AML. METHODOLOGY: This open-label phase 1/2 (P1/2) study was conducted in 47 Japanese patients aged 60-75 years with newly diagnosed high-risk AML to evaluate the pharmacokinetics, safety, and efficacy of NS-87/CPX-351.

resultsIn the 6 patients enrolled in the P1 portion, no dose-limiting toxicities (DLTs) were reported, and 100 units/m OUTCOMES: NS-87/CPX-351 can be considered as a frontline treatment option for Japanese patients with high-risk AML.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCytarabineDaunorubicinLeukemia, Myeloid, AcuteLiposomesAgedEast Asian PeopleFemaleHumansJapanJapanese peopleMaleMiddle AgedTreatment OutcomeCPX-351CytarabineDaunorubicinLiposomesAcute myeloid leukemiaCPX-351CytarabineDaunorubicinLiposomal formulation

Identifiers

PMID38532078
PMCPMC11136735
OpenAlexW4393187220

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.