Evidence map›Paper›PMID 40365847›Full record

Trial reportCancer science2025

PI3Kδ Inhibitor Parsaclisib in Japanese Patients With Relapsed or Refractory Follicular Lymphoma.

Noriko Fukuhara, Isao Yoshida, Takuro Ishiguro, Katsuya Fujimoto, Junya Kuroda, Toshiki Uchida, Ryusuke Yamamoto, Yoshiaki Ogawa, Yasushi Hiramatsu, Toshiro Ito and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04434937 (A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04434937 phase2completednot on this map

A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

TypeinterventionalSponsorIncyte Biosciences Japan GKRan2020 to 2023Enrolled42ConditionsLymphomaArmsparsaclisib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

16 authors.

Noriko FukuharaTohoku University Hospital, Sendai, Japan.ORCID https://orcid.org/0000-0003-2682-2179
Isao YoshidaNHO Shikoku Cancer Center, Matsuyama, Japan.
Takuro IshiguroNiigata Cancer Center Hospital, Niigata, Japan.
Katsuya FujimotoNHO Hokkaido Cancer Center, Sapporo, Japan.
Junya KurodaKyoto Prefectural University of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0001-6130-1550
Toshiki UchidaJapanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.
Ryusuke YamamotoKobe City Medical Center General Hospital, Kobe, Japan.
Yoshiaki OgawaTokai University Hospital, Tokyo, Japan.
Yasushi HiramatsuJapanese Red Cross Society Himeji Hospital, Himeji, Japan.
Toshiro ItoNHO Matsumoto Medical Center, Matsumoto, Japan.
Seiichiro KatagiriTokyo Medical University Hospital, Tokyo, Japan.
Tomonori NakazatoYokohama Municipal Citizen's Hospital, Yokohama, Japan.
Kazumi SuzukawaIncyte Biosciences Japan G.K., Tokyo, Japan.
Kenzo KinamiIncyte Biosciences Japan G.K., Tokyo, Japan.
Mi ZhouIncyte Corporation, Wilmington, Delaware, USA.
Eiju NegoroUniversity of Fukui, Fukui, Japan.

Funding

Incyte Corporation
6 · The paper itself

Abstract

Follicular lymphoma (FL) is the second most common subtype of non-Hodgkin lymphoma (NHL) in Japan, the United States, and Western Europe. Parsaclisib is a potent, selective next-generation PI3Kδ inhibitor that has demonstrated clinical efficacy and tolerability in phase II studies of patients with relapsed or refractory (R/R) B-cell NHL, including FL. We report results from CITADEL-213 (NCT04434937), a phase II study evaluating the efficacy and safety of parsaclisib in Japanese patients with R/R FL. Eligible patients were aged ≥ 18 years with histologically confirmed R/R FL (grade 1, 2, or 3a), had received two or more prior systemic therapies, and were ineligible for hematopoietic stem cell transplantation. Patients received parsaclisib 20 mg once daily for 8 weeks, followed by parsaclisib 2.5 mg once daily thereafter. The primary endpoint was the objective response rate (ORR). At the data cut-off (February 16, 2023), 42 patients had received treatment with parsaclisib, of whom 41 were evaluable for change in target tumor size. Median (range) age at baseline was 66.5 (52-87) years. ORR (95% confidence interval [CI]) was 88.1% (74.4-96.0), with 10 patients (23.8%) experiencing a complete response and 27 patients (64.3%) experiencing a partial response. Median (95% CI) duration of response was not reached (8.0 months-not estimable). The most common treatment-emergent adverse events (TEAEs) were diarrhea (28.6%; grade ≥ 3, 7.1%) and stomatitis (23.8%; grade ≥ 3, 11.9%); TEAEs led to parsaclisib discontinuation in five patients (11.9%). There were no fatal TEAEs. In conclusion, parsaclisib monotherapy demonstrated durable responses with a manageable safety profile in Japanese patients with R/R FL. Trial Registration: ClinicalTrials.gov, NCT04434937.

Indexed as

Class I Phosphatidylinositol 3-KinasesLymphoma, FollicularNeoplasm Recurrence, LocalSulfonamidesAgedAged, 80 and overDrug Resistance, NeoplasmEast Asian PeopleFemaleHumansJapanMaleMiddle AgedTreatment OutcomeClass I Phosphatidylinositol 3-KinasesPIK3CD protein, humanSulfonamidesfollicular lymphomanon‐Hodgkin lymphomaobjective response rateparsaclisibphosphatidylinositol 3‐kinase

Identifiers

PMID40365847
PMCPMC12317384

What Socratic 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 Socratic graph.