Evidence map›Paper›PMID 34865212›Full record

ArticleBritish journal of haematology2022

Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials.

John N Allan, Tait Shanafelt, Adrian Wiestner, Carol Moreno, Susan M O'Brien, Jianling Li, Gabriel Krigsfeld, James P Dean, Inhye E Ahn

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in British journal of haematology, 2022. 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 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT01500733 phase2active not recruitingnot on this map

A Phase II Study of PCI-32765 for Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Need Therapy and Are Older Than 65 or Have a 17p Deletion

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2012 to 2034Enrolled86ConditionsLeukemia, Leukemia, Lymphocytyc, CLL (Chronic Lymphocytic Leukemia), SLL (Small Lymphocytic Lymphoma)ArmsPCI 32765
NCT01722487 phase3completednot on this map

Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

TypeinterventionalSponsorPharmacyclics LLC.Ran2013 to 2015Enrolled269ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsIbrutinib, Chlorambucil
NCT02048813 phase3active not recruitingnot on this map

A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2026Enrolled529ConditionsAnemia, Chronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsCyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study
NCT02264574 phase3completednot on this map

A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

TypeinterventionalSponsorPharmacyclics LLC.Ran2014 to 2019Enrolled229ConditionsChronic Lymphocytic Leukemia, Small-Cell LymphomaArmsIbrutinib, Obinutuzumab, Chlorambucil
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. ComplexInternational journal of molecular sciences · 2026
    Review
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  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Greek Consensus on Chronic Lymphocytic Leukemia (CLL) Treatment.Mediterranean journal of hematology and infectious diseases · 2025
    Article
  17. Article
  18. Review
  19. Review
  20. 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

9 authors at 6 institutions in 2 countries.

John N AllanWeill Cornell Medicine, New York, NY, USA.ORCID 0000-0002-2088-0899
Tait ShanafeltStanford University Medical Center, Stanford, CA, USA.
Adrian WiestnerNational Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Carol MorenoHospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.ORCID 0000-0003-3275-0271
Susan M O'BrienChao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA, USA.
Jianling LiPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Gabriel KrigsfeldPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
James P DeanPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Inhye E AhnNational Heart, Lung, and Blood Institute, Bethesda, MD, USA.
AbbVie (United States) · USNational Heart Lung and Blood Institute · USCornell University · USStanford Medicine · USUniversitat Autònoma de Barcelona · ESUniversity of California, Irvine · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Tumor microenvironment in CLL and MCL: pathogenesis, targets, and therapyZIAHL002346 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI WIESTNER, ADRIAN U · 2009 to 2025
$29.8M
NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA196172
6 · The paper itself

Abstract

TP53 aberrations [del(17p) or TP53 mutation] predict poor survival with chemoimmunotherapy in patients with chronic lymphocytic leukaemia (CLL). We evaluated long-term efficacy and safety of first-line ibrutinib-based therapy in patients with CLL bearing TP53 aberrations in a pooled analysis across four studies: PCYC-1122e, RESONATE-2 (PCYC-1115/16), iLLUMINATE (PCYC-1130) and ECOG-ACRIN E1912. The pooled analysis included 89 patients with TP53 aberrations receiving first-line treatment with single-agent ibrutinib (n = 45) or ibrutinib in combination with an anti-CD20 antibody (n = 44). All 89 patients had del(17p) (53% of 89 patients) and/or TP53 mutation (91% of 58 patients with TP53 sequencing results available). With a median follow-up of 49·8 months (range, 0·1-95·9), median progression-free survival was not reached. Progression-free survival rate and overall survival rate estimates at four years were 79% and 88%, respectively. Overall response rate was 93%, including complete response in 39% of patients. No new safety signals were identified in this analysis. Forty-six percent of patients remained on ibrutinib treatment at last follow-up. With median follow-up of four years (up to eight years), results from this large, pooled, multi-study data set suggest promising long-term outcomes of first-line ibrutinib-based therapy in patients with TP53 aberrations. Registered at ClinicalTrials.gov (NCT01500733, NCT01722487, NCT02264574 and NCT02048813).

Indexed as

AdenineAdultAgedAged, 80 and overClinical Trials as TopicFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesTumor Suppressor Protein p53AdenineibrutinibPiperidinesTumor Suppressor Protein p53chronic lymphocytic leukaemiadel(17p)first-lineibrutinibTP53 mutation

Identifiers

PMID34865212
PMCPMC9299890
OpenAlexW4200435825

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.