Evidence map›Paper›PMID 36661315›Full record

Trial reportBlood advances2023

Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study.

Won-Seog Kim, Noriko Fukuhara, Dok-Hyun Yoon, Kazuhito Yamamoto, Toshiki Uchida, Eiju Negoro, Koji Izutsu, Yasuhito Terui, Hideaki Nakajima, Kiyoshi Ando and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02653976 (Asian Multinational Phase 2 Study of SP-02L), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.6field-weighted citation impact, top 12% 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.

NCT02653976 phase2completednot on this map

Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

TypeinterventionalSponsorSolasia Pharma K.K.Ran2016 to 2021Enrolled67ConditionsPeripheral T-Cell LymphomaArmsSP-02L (darinaparsin for injection)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Novel agents and therapeutic advances in T cell lymphoma.International journal of hematology · 2026
    Review
  3. Article
  4. Article
  5. 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

19 authors at 16 institutions in 4 countries.

Won-Seog KimSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Noriko FukuharaTohoku University Hospital, Sendai, Japan.ORCID 0000-0003-2682-2179
Dok-Hyun YoonAsan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kazuhito YamamotoAichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-8588-8955
Toshiki UchidaJapanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.
Eiju NegoroUniversity of Fukui Hospital, Fukui, Japan.
Koji IzutsuNational Cancer Center Hospital, Tokyo, Japan.
Yasuhito TeruiThe Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Hideaki NakajimaYokohama City University Hospital, Yokohama, Japan.
Kiyoshi AndoTokai University Hospital, Isehara, Japan.
Youko SuehiroNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Hye Jin KangKorea Cancer Center Hospital, Seoul, Korea.
Po-Shen KoTaipei Veterans General Hospital, Taipei, Taiwan.ORCID 0000-0001-9299-0352
Fumiko NagahamaSolasia Pharma K.K., Tokyo, Japan.ORCID 0000-0003-2891-0236
Yusuke SoneharaSolasia Pharma K.K., Tokyo, Japan.
Hirokazu NagaiNational Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Hwei-Fang TienNational Taiwan University Hospital, Taipei, Taiwan.
Yok-Lam KwongQueen Mary Hospital, Hong Kong.
Kensei TobinaiNational Cancer Center Hospital, Tokyo, Japan.
EA Pharma (Japan) · JPTokyo National Hospital · JPAichi Cancer Center · JPJapanese Red Cross Nagoya Daini Hospital · JPNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPNational Taiwan University Hospital · TWQueen Mary Hospital · CNSamsung Medical Center · KRTaipei Veterans General Hospital · TWThe Cancer Institute Hospital · JPTohoku University Hospital · JPTokai University Hospital · JPUlsan College · KRUniversity of Fukui Hospital · JPYokohama City University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Darinaparsin is a novel organic arsenical compound of dimethylated arsenic conjugated to glutathione, with antitumor activity and a mechanism of action markedly different from other available agents. This phase 2, nonrandomized, single-arm, open-label study evaluated the efficacy and safety of intravenous darinaparsin (300 mg/m2 over 1 hour, once daily for 5 consecutive days, per 21-day cycle) and its pharmacokinetics at multiple doses in 65 Asian patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary end point was the overall response rate (ORR). The ORR based on central assessment was 19.3% (90% confidence interval, 11.2-29.9), which was significantly higher than the predefined threshold of 10% (P = .024). The ORR was 16.2% in patients with PTCL-not otherwise specified and 29.4% in patients with angioimmunoblastic T-cell lymphoma. Tumor size decreased in 62.3% of patients. Treatment-emergent adverse events (TEAEs) were observed in 98.5% of patients. Grade ≥3 TEAEs with an incidence rate of ≥5% included anemia (15.4%), thrombocytopenia (13.8%), neutropenia (12.3%), leukopenia (9.2%), lymphopenia (9.2%), and hypertension (6.2%). Darinaparsin is effective and well tolerated, with TEAEs that were clinically acceptable and manageable with symptomatic treatment and dose reductions. This trial was registered at www.clinicaltrials.gov as #NCT02653976.

Indexed as

ArsenicalsLymphoma, T-Cell, PeripheralNeutropeniaGlutathioneHumansArsenicalsdarinaparsinGlutathione

Identifiers

PMID36661315
PMCPMC10463191
OpenAlexW4317538396

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.