Evidence map›Paper›PMID 35579212›Full record

ArticleCancer science2022

Oral histone deacetylase inhibitor tucidinostat (HBI-8000) in patients with relapsed or refractory adult T-cell leukemia/lymphoma: Phase IIb results.

Atae Utsunomiya, Koji Izutsu, Tatsuro Jo, Shinichiro Yoshida, Kunihiro Tsukasaki, Kiyoshi Ando, Ilseung Choi, Yoshitaka Imaizumi, Koji Kato, Mitsutoshi Kurosawa and 14 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02955589 (A Phase 2b Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma), which is not on this map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 5% 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.

NCT02955589 phase2completednot on this map

A Phase 2b Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

TypeinterventionalSponsorHUYABIO International, LLC.Ran2016 to 2019Enrolled23ConditionsAdult T-Cell Lymphoma (ATL)ArmsHBI-8000
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Novel agents and therapeutic advances in T cell lymphoma.International journal of hematology · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Clinical progress and functional modalities of HDAC inhibitor-based combination therapies in cancer treatment.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  13. Article
  14. Article
  15. Pathobiological link between CD30 and abnormal lymphocytes in adult T-cell leukemia/lymphoma.Journal of clinical and experimental hematopathology : JCEH · 2025
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article
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 20 institutions in 2 countries.

Atae UtsunomiyaDepartment of Hematology, Imamura General Hospital, Kagoshima, Japan.ORCID https://orcid.org/0000-0002-8843-406X
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9129-8057
Tatsuro JoDepartment of Hematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Shinichiro YoshidaDepartment of Hematology, National Hospital Organization Nagasaki Medical Center, Japan.
Kunihiro TsukasakiDepartment of Hematology, International Medical Center, Saitama Medical University, Saitama, Japan.
Kiyoshi AndoDepartment of Hematology/Oncology, Tokai University Hospital, Kanagawa, Japan.
Ilseung ChoiDepartment of Hematology, NHO Kyushu Cancer Center, Fukuoka, Japan.
Yoshitaka ImaizumiDepartment of Hematology, Nagasaki University Hospital, Nagasaki, Japan.ORCID https://orcid.org/0000-0002-2954-5691
Koji KatoDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-5815-4585
Mitsutoshi KurosawaDepartment of Hematology, Hokkaido Cancer Center, Sapporo, Japan.
Shigeru KusumotoDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.ORCID https://orcid.org/0000-0001-6546-1279
Takashi MiyagiDepartment of Hematology, Heartlife Hospital, Okinawa, Japan.
Eiichi OhtsukaDepartment of Hematology, Oita Prefectural Hospital, Oita, Japan.
Osamu SasakiDivision of Hematology, Miyagi Cancer Center, Miyagi, Japan.
Hirohiko ShibayamaDepartment of Hematology and Oncology, Osaka University Hospital, Suita, Japan.
Kazuya ShimodaDivision of Hematology, Diabetes and Endocrinology, Department of Internal Medicine, University of Miyazaki, Miyazaki, Japan.
Yasushi TakamatsuDepartment of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan.
Kuniko TakanoDepartment of Medical Oncology and Hematology, Faculty of Medicine, Oita University Hospital, Oita University, Oita, Japan.
Kentaro YonekuraDepartment of Dermatology, Imamura General Hospital, Kagoshima, Japan.ORCID https://orcid.org/0000-0002-9030-247X
Shinichi MakitaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0001-6609-8088
Jun TaguchiDepartment of Hematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Mireille GillingsHUYABIO International, CEO, Corporate Office, San Diego, California, USA.
Hiroshi OnogiResearch & Development, Huya Japan GK, Tokyo, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Tokyo National Hospital · JPImamura Hospital · JPJapanese Red Cross Society, Japan · JPDevelopment Bank of Japan · JPFukuoka University Hospital · JPHeart Life Hospital · JPISCO International (United States) · USKyushu University Hospital · JPMiyagi Prefectural Hospital Organization · JPNagasaki Medical Center · JPNagasaki University Hospital · JPNagoya City University · JPNational Hospital Organization Hokkaido Medical Center · JPNational Hospital Organization Kyushu Cancer Center · JPOita Prefectural Hospital · JPOita University Hospital · JPOsaka University Hospital · JPSaitama International Medical Center · JPTokai University Hospital · JPUniversity of Miyazaki · JP

Funding

The study was funded by HUYABIO International, LLC.
6 · The paper itself

Abstract

This multicenter, prospective phase IIb trial evaluating the efficacy and safety of tucidinostat (HBI-8000) in patients with relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL) was undertaken in Japan. Eligible patients had R/R ATLL and had failed standard of care treatment with chemotherapy and with mogamulizumab. Twenty-three patients received tucidinostat 40 mg orally twice per week and were included in efficacy and safety analyses. The primary end-point was objective response rate (ORR) assessed by an independent committee. The ORR was 30.4% (95% confidence interval [CI], 13.2, 52.9]. Median progression-free survival was 1.7 months (95% CI, 0.8, 7.4), median duration of response was 9.2 months (95% CI, 2.6, not reached), and median overall survival was 7.9 months (95% CI, 2.3, 18.0). All patients experienced adverse events (AEs), which were predominantly hematologic and gastrointestinal. Incidence of grade 3 or higher AEs was 78.3%; most were laboratory abnormalities (decreases in platelets, neutrophils, white blood cells, and hemoglobin). Tucidinostat was well tolerated with AEs that could be mostly managed with supportive care and dose modifications. Tucidinostat is a meaningful treatment option for R/R ATLL patients; further investigation is warranted.

Indexed as

Leukemia-Lymphoma, Adult T-CellLymphoma, FollicularAdultBenzamidesHistone Deacetylase InhibitorsHumansProspective StudiesPyridinesRecurrenceTreatment OutcomeBenzamidesHBI-8000Histone Deacetylase InhibitorsPyridinesATLLHBI-8000HDAC inhibitorORRtucidinostat

Identifiers

PMID35579212
PMCPMC9357668
OpenAlexW4280517695

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.