Evidence map›Paper›PMID 36200417›Full record

ArticleHaematologica2023

Oral HDAC inhibitor tucidinostat in patients with relapsed or refractory peripheral T-cell lymphoma: phase IIb results.

Shinya Rai, Won Seog Kim, Kiyoshi Ando, Ilseung Choi, Koji Izutsu, Norifumi Tsukamoto, Masahiro Yokoyama, Kunihiro Tsukasaki, Junya Kuroda, Jun Ando and 22 more

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

Article in Haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02953652 (A Phase 2b Open-Label Single Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma), which is not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 4% 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.

NCT02953652 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 Peripheral T-cell Lymphoma (PTCL)

TypeinterventionalSponsorHUYABIO International, LLC.Ran2016 to 2022Enrolled55ConditionsPeripheral T-Cell Lymphoma (PTCL)ArmsHBI-8000
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. ACS pharmacology & translational science · 2025
    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

32 authors at 20 institutions in 2 countries.

Shinya RaiKindai University Hospital, Osaka-Sayama. rai@med.kindai.ac.jp.
Won Seog KimSamsung Medical Center Sungkyunkwan University School of Medicine, Seoul.
Kiyoshi AndoTokai University Hospital, Isehara.
Ilseung ChoiNational Hospital Organization Kyushu Cancer Center, Fukuoka.
Koji IzutsuNational Cancer Center Hospital, Tokyo.
Norifumi TsukamotoGunma University Hospital, Maebashi.
Masahiro YokoyamaThe Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo.
Kunihiro TsukasakiInternational Medical Center, Saitama Medical University, Saitama.
Junya KurodaKyoto Prefectural University of Medicine, Kyoto.
Jun AndoJuntendo University Hospital, Tokyo.
Michihiro HidakaNational Hospital Organization Kumamoto Medical Center, Kumamoto.
Youngil KohSeoul National University Hospital, Seoul.
Hirohiko ShibayamaOsaka University Hospital, Suita.
Toshiki UchidaJapanese Red Cross Nagoya Daini Hospital, Nagoya.
Deok Hwan YangChonnam National University Hwasun Hospital, Jeollanam.
Kenji IshitsukaKagoshima University Hospital, Kagoshima.
Kenichi IshizawaYamagata University Hospital, Yamagata.
Jin Seok KimYonsei University College of Medicine, Severance Hospital, Seoul.
Hong Ghi LeeKonkuk University Medical Center, Seoul.
Hironobu MinamiKobe University Graduate School of Medicine and Hospital, Kobe.
Hyeon Seok EomNational Cancer Center, Gyeonggi.
Mitsutoshi KurosawaNational Hospital Organization Hokkaido Cancer Center, Sapporo.
Jae Hoon LeeGachon University Gil Medical Center, Incheon.
Jong Seok LeeSeoul National University Bundang Hospital, Gyeonggi.
Won Sik LeeInje University Busan Paik Hospital, Busan.
Hirokazu NagaiNational Hospital Organization Nagoya Medical Center, Nagoya.
Takero ShindoKyoto University Hospital, Kyoto.
Dok Hyun YoonAsan Medical Center, University of Ulsan College of Medicine, Seoul.
Shinichiro YoshidaNational Hospital Organization Nagasaki Medical Center, Omura.
Mireille GillingsHUYABIO International, San Diego, CA.
Hiroshi OnogiHuya Japan GK, Tokyo.
Kensei TobinaiNational Cancer Center Hospital, Tokyo.
Tokyo National Hospital · JPAsan Medical Center · KRChonnam National University Hwasun Hospital · KRGachon University Gil Medical Center · KRGunma University Hospital · JPInje University Busan Paik Hospital · KRJapanese Foundation For Cancer Research · JPJapanese Red Cross Nagoya Daini Hospital · JPJuntendo University Hospital · JPKagoshima University Hospital · JPKindai University Hospital · JPKobe University Hospital · JPKonkuk University Medical Center · KRKumamoto Medical Center · JPKyoto Prefectural University of Medicine · JPKyoto University Hospital · JPNagasaki Medical Center · JPNagoya Medical Center · JPNational Cancer Center · KRNational Hospital Organization Hokkaido Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tucidinostat (formerly known as chidamide) is an orally available, novel benzamide class of histone deacetylase (HDAC) inhibitor that selectively blocks class I and class IIb HDAC. This multicenter phase IIb study aimed to investigate the efficacy and safety of tucidinostat, 40 mg twice per week (BIW), in patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). The primary endpoint was overall response rate (ORR) assessed by an independent overall efficacy review committee. Between March 2017 and March 2019, 55 patients were treated, and 46 and 55 were evaluated for efficacy and safety, respectively. Twenty-one of 46 patients achieved objective responses with an ORR of 46% (95% confidence interval : 30.9-61.0), including five patients with complete response (CR). Responses were observed across various PTCL subtypes. In angioimmunoblastic T-cell lymphoma, there were two CR and five partial responses (PR) among eight patients, achieving an ORR of 88%. The disease control rate (CR + PR + stable disease) was 72% (33/46). The median progression-free survival, duration of response, and overall survival were 5.6 months, 11.5 months, 22.8 months, respectively. The most common adverse events (AE) (all grades) were thrombocytopenia, neutropenia, leukopenia, anemia, and diarrhea. The grade ≥3 AE emerging in ≥20% of patients included thrombocytopenia (51%), neutropenia (36%), lymphopenia (22%), and leukopenia (20%). Importantly, most of the AE were manageable by supportive care and dose modification. In conclusion, the favorable efficacy and safety profiles indicate that tucidinostat could be a new therapeutic option in patients with R/R PTCL (clinicaltrials gov. Identifier: NCT02953652).

Indexed as

Lymphoma, T-Cell, PeripheralNeutropeniaThrombocytopeniaAminopyridinesBenzamidesHistone Deacetylase InhibitorsHumansNeoplasm Recurrence, LocalTreatment OutcomeAminopyridinesBenzamidesHistone Deacetylase InhibitorsN-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Identifiers

PMID36200417
PMCPMC9973490
OpenAlexW4302287973

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.