Evidence map›Paper›PMID 24615776›Full record

ArticleBlood2014

Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-δ, as therapy for previously treated indolent non-Hodgkin lymphoma.

Ian W Flinn, Brad S Kahl, John P Leonard, Richard R Furman, Jennifer R Brown, John C Byrd, Nina D Wagner-Johnston, Steve E Coutre, Don M Benson, Sissy Peterman and 8 more

4 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 101 papers.

0numbers the graph read from it
0cells of the map it votes in
101citing 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.

NCT00710528 phase1completednot on this map

A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies

TypeinterventionalSponsorGilead SciencesRan2008 to 2012Enrolled192ConditionsChronic Lymphocytic Leukemia (CLL), Lymphoma, Non-Hodgkin (NHL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM)ArmsCAL-101
NCT01090414 phase1 / phase2terminatednot on this map

An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies

TypeinterventionalSponsorGilead SciencesRan2010 to 2018Enrolled202ConditionsChronic Lymphocytic Leukemia, Lymphoma, Non-HodgkinArmsIdelalisib
NCT03757000 phase1unknown statusnot on this mapstarted 2017, after this paper: background citation

A Phase I Study of YY-20394 Given Orally to Patients With Relapsed or Refractory B Cell Hematologic Malignancies

TypeinterventionalSponsorShanghai YingLi Pharmaceutical Co. Ltd.Ran2017 to 2019Enrolled42ConditionsB-cell Lymphoma Recurrent, B-cell Chronic Lymphocytic LeukemiaArmsYY-20394
NCT04049929 phase1unknown statusnot on this mapstarted 2019, after this paper: background citation

A Single-Arm, Open-Label, Multi-Center, Phase I Study of YY-20394 in Patients With Advanced Solid Tumors

TypeinterventionalSponsorShanghai YingLi Pharmaceutical Co. Ltd.Ran2019 to 2020Enrolled50ConditionsAdvanced Solid TumorArmsYY-20394
3 · Its place in the literature

Who cites it

101 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Phase I/Ib Study of the Efficacy and Safety of Buparlisib and Ibrutinib Therapy in MCL, FL, and DLBCL with Serial Cell-Free DNA Monitoring.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  16. Article
  17. Article
  18. Review
  19. PI3K inhibitors are finally coming of age.Nature reviews. Drug discovery · 2021
    Review
  20. Review

41 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

18 authors.

Ian W FlinnSarah Cannon Research Institute, Nashville, TN;
Brad S KahlUniversity of Wisconsin Carbone Cancer Center, Madison, WI;
John P LeonardWeill Cornell Medical College, New York, NY;
Richard R FurmanWeill Cornell Medical College, New York, NY;
Jennifer R BrownDana-Farber Cancer Institute, Boston, MA;
John C ByrdThe Ohio State University, Columbus, OH;
Nina D Wagner-JohnstonWashington University School of Medicine, St. Louis, MO;
Steve E CoutreStanford University Cancer Center, Stanford, CA;
Don M BensonThe Ohio State University, Columbus, OH;
Sissy PetermanGilead Sciences, Seattle, WA; and.
Yoonjin ChoGilead Sciences, Seattle, WA; and.
Heather K WebbGilead Sciences, Seattle, WA; and.
David M JohnsonGilead Sciences, Seattle, WA; and.
Albert S YuGilead Sciences, Seattle, WA; and.
Roger G UlrichGilead Sciences, Seattle, WA; and.
Wayne R GodfreyGilead Sciences, Seattle, WA; and.
Langdon L MillerGilead Sciences, Seattle, WA; and.
Stephen E SpurgeonOregon Health and Sciences University, Portland, OR.

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
NCATS NIH HHS UL1 TR000427NCI NIH HHS P30 CA014520
6 · The paper itself

Abstract

Idelalisib (GS-1101, CAL-101), an oral inhibitor of phosphatidylinositol 3-kinase-δ, was evaluated in a phase I study in 64 patients with relapsed indolent non-Hodgkin lymphoma (iNHL). Patients had a median (range) age of 64 (32-91) years, 34 (53%) had bulky disease (≥1 lymph nodes ≥5 cm), and 37 (58%) had refractory disease. Patients had received a median (range) of 4 (1-10) prior therapies. Eight dose regimens of idelalisib were evaluated; idelalisib was taken once or twice daily continuously at doses ranging from 50 to 350 mg. After 48 weeks, patients still benefitting (n = 19; 30%) enrolled into an extension study. Adverse events (AEs) occurring in 20% or more patients (total%/grade ≥3%) included diarrhea (36/8), fatigue (36/3), nausea (25/3), rash (25/3), pyrexia (20/3), and chills (20/0). Laboratory abnormalities included neutropenia (44/23), anemia (31/5), thrombocytopenia (25/11), and serum transaminase elevations (48/25). Twelve (19%) patients discontinued therapy due to AEs. Idelalisib induced disease regression in 46/54 (85%) of evaluable patients achieving an overall response rate of 30/64 (47%), with 1 patient having a complete response (1.6%). Median duration of response was 18.4 months, median progression-free survival was 7.6 months. Idelalisib is well tolerated and active in heavily pretreated, relapsed/refractory patients with iNHL. These trials were registered at clinicaltrials.gov as NCT00710528 and NCT01090414.

Indexed as

Phosphoinositide-3 Kinase InhibitorsAdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansLymphoma, Non-HodgkinMaleMiddle AgedNeoplasm GradingPurinesQuinazolinonesSalvage TherapyTreatment OutcomeAntineoplastic AgentsidelalisibPhosphoinositide-3 Kinase InhibitorsPurinesQuinazolinones

Identifiers

PMID24615776
PMCPMC4260978

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.