Evidence map›Paper›PMID 30803990›Full record

Trial reportBlood2019

Parsaclisib, a potent and highly selective PI3Kδ inhibitor, in patients with relapsed or refractory B-cell malignancies.

Andres Forero-Torres, Radhakrishnan Ramchandren, Abdulraheem Yacoub, Michael S Wertheim, William J Edenfield, Paolo Caimi, Martin Gutierrez, Luke Akard, Carolina Escobar, Justin Call and 7 more

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

Trial report in Blood, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02018861 (A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Iitacitinib in Subjects With Previously Treated B-Cell Malignancies), which is not on this map. Cited by 64 papers.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed
7.8field-weighted citation impact, top 2% 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.

NCT02018861 phase1 / phase2completednot on this map

A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Iitacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

TypeinterventionalSponsorIncyte CorporationRan2016 to 2021Enrolled88ConditionsB-Cell MalignanciesArmsParsaclisib, Itacitinib, Rituximab, Ifosfamide, Carboplatin
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 98 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Ir/Ni Metallaphotoredox Catalysis for the C(spChemistry (Weinheim an der Bergstrasse, Germany) · 2025
    Article
  14. Molecular biology of the novel anticancer medications: a focus on kinases inhibitors, biologics and CAR T-cell therapy.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2025
    Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Small-molecule agents for cancer immunotherapy.Acta pharmaceutica Sinica. B · 2024
    Review

4 more citing papers are in PubMed but not listed here.

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

17 authors at 14 institutions in 1 country.

Andres Forero-TorresDivision of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL.
Radhakrishnan RamchandrenKarmanos Cancer Center, Detroit, MI.
Abdulraheem YacoubUniversity of Kansas Cancer Center, Westwood, KS.
Michael S WertheimHematology/Oncology Associates of Treasure Coast, Port St. Lucie, FL.
William J EdenfieldGreenville Health System Cancer Institute, Greenville, SC.
Paolo CaimiUniversity Hospitals Seidman Cancer Center, Cleveland, OH.
Martin GutierrezHackensack University Medical Center, Hackensack, NJ.
Luke AkardIndiana Blood & Marrow Transplantation, LLC, Indianapolis, IN.
Carolina EscobarTexas Oncology-Baylor Charles A. Sammons Cancer Center Blood and Marrow Transplant, Dallas, TX.
Justin CallUtah Cancer Specialists Network, Salt Lake City, UT.
Daniel PerskyUniversity of Arizona Cancer Center, Tucson, AZ.
Swaminathan IyerHouston Methodist Cancer Center, Houston, TX.
Douglas J DeMariniIncyte Corporation, Wilmington, DE; and.
Li ZhouIncyte Corporation, Wilmington, DE; and.
Xuejun ChenIncyte Corporation, Wilmington, DE; and.
Fitzroy DawkinsIncyte Corporation, Wilmington, DE; and.
Tycel J PhillipsDivision of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.
Incyte (United States) · USHackensack University Medical Center · USHematology Oncology Associates · USHouston Methodist · USIndiana Cancer Consortium · USPrisma Health · USTexas Oncology · USThe Barbara Ann Karmanos Cancer Institute · USThe University of Kansas Cancer Center · USUniversity Hospitals Seidman Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of Arizona · USUniversity of Michigan–Ann Arbor · USUtah Cancer Specialists · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 1/2 study assessed parsaclisib (INCB050465), a next-generation, potent, and highly selective phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor, in patients with relapsed or refractory B-cell malignancies, alone or in combination with a Janus kinase 1 inhibitor (itacitinib) or chemotherapy (rituximab, ifosfamide, carboplatin, and etoposide). Seventy-two patients received parsaclisib monotherapy (5-45 mg once daily). Expansion doses were 20 and 30 mg once daily; intermittent dosing at 20 mg (once daily for 9 weeks, then once weekly) was explored. No dose-limiting toxicities were identified, and maximum tolerated dose was not reached. Most common nonhematologic treatment-emergent adverse events (TEAEs) were diarrhea/colitis (36%), nausea (36%), fatigue (31%), and rash (31%). Grade 3/4 neutropenia occurred in 19% of patients. Serious TEAEs (>2 patients) were diarrhea/colitis (n = 9), pyrexia (n = 4), hypotension (n = 3), and sepsis (n = 3). Aspartate and alanine transaminase elevations occurring before treatment discontinuation were grade 1, except 1 grade 3 event each, secondary to sepsis. Two patients experienced 3 fatal parsaclisib-unrelated TEAEs (respiratory failure; respiratory failure and sepsis). In non-Hodgkin lymphoma (NHL), objective response rates to monotherapy were 71% in follicular lymphoma, 78% in marginal zone lymphoma, 67% in mantle cell lymphoma, and 30% in diffuse large B-cell lymphoma; 93% of responses occurred at first assessment (∼9 weeks). Parsaclisib has demonstrated antitumor activity in relapsed or refractory B-cell NHL with the potential for improved long-term patient outcomes. Phase 2 studies in relapsed or refractory B-cell NHL subtypes are ongoing. This trial was registered at www.clinicaltrials.gov as #NCT02018861.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDrug Administration ScheduleFemaleHumansLeukemia, B-CellLymphoma, B-CellMaleMiddle AgedProtein Kinase InhibitorsPyrazolesPyrimidinesPyrrolidinesSalvage TherapyTreatment OutcomeparsaclisibProtein Kinase InhibitorsPyrazolesPyrimidinesPyrrolidines

Identifiers

PMID30803990
PMCPMC6543513
OpenAlexW2917721259

What OpenQuestion holds

Textmetadata
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.