Evidence map›Paper›PMID 31088809›Full record

Trial reportBlood advances2019

Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib.

Farrukh T Awan, Anna Schuh, Jennifer R Brown, Richard R Furman, John M Pagel, Peter Hillmen, Deborah M Stephens, Jennifer Woyach, Elena Bibikova, Prista Charuworn and 7 more

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

Trial report in Blood advances, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02029443 (A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia), which is not on this map. Cited by 101 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 2 pooled it
–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.

NCT02029443 phase1 / phase2active not recruitingnot on this map

A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

TypeinterventionalSponsorAcerta Pharma BVRan2014 to 2027Enrolled306ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Prolymphocytic LeukemiaArmsAcalabrutinib
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  4. Trial
  5. Trial
  6. Trial
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  8. Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. Management of Relapsed and/or Refractory Chronic Lymphocytic Leukemia.Hematology/oncology clinics of North America · 2025
    Review
  14. Current and future landscape of Bruton tyrosine kinase inhibitors in allergy.The Journal of allergy and clinical immunology · 2025
    Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  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

17 authors.

Farrukh T AwanHarold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0003-1813-9812
Anna SchuhDepartment of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Jennifer R BrownDana-Farber Cancer Institute, Boston, MA.
Richard R FurmanNew York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY.
John M PagelSwedish Cancer Institute, Seattle, WA.
Peter HillmenSt. James's University Hospital, Leeds, United Kingdom.ORCID 0000-0001-5617-4403
Deborah M StephensHuntsman Cancer Institute, University of Utah, Salt Lake City, UT.ORCID 0000-0001-9188-5008
Jennifer WoyachThe Ohio State University Comprehensive Cancer Center, Columbus, OH.
Elena BibikovaAcerta Pharma, South San Francisco, CA.
Prista CharuwornAcerta Pharma, South San Francisco, CA.
Melanie M FrigaultAcerta Pharma, South San Francisco, CA.
Ahmed HamdyAcerta Pharma, South San Francisco, CA.
Raquel IzumiAcerta Pharma, South San Francisco, CA.
Bolan LinghuOncology Biosciences, IMED Biotech Unit, AstraZeneca, Boston, MA.
Priti PatelAcerta Pharma, South San Francisco, CA.
Min Hui WangAcerta Pharma, South San Francisco, CA.
John C ByrdThe Ohio State University Comprehensive Cancer Center, Columbus, OH.

Funding

Targeted Therapy for LeukemiaR35CA197734 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2015 to 2021
$6.6M
Targeted Therapy for Lymphoid MalignanciesR01CA177292 · NCI · OHIO STATE UNIVERSITY · PI ROGERS, KERRY ANNE, WOYACH, JENNIFER A. · 2013 to 2025
$5.3M
NCI NIH HHS R01 CA177292NCI NIH HHS R35 CA197734
6 · The paper itself

Abstract

The Bruton tyrosine kinase (BTK) inhibitor ibrutinib improves patient outcomes in chronic lymphocytic leukemia (CLL); however, some patients experience adverse events (AEs) leading to discontinuation. Acalabrutinib is a potent, covalent BTK inhibitor with greater selectivity than ibrutinib. We evaluated the safety and efficacy of 100 mg of acalabrutinib twice daily or 200 mg once daily in patients with CLL who discontinued ibrutinib because of intolerance as determined by the investigators. Among 33 treated patients (61% men; median age, 64 years; range, 50-82 years), median duration of prior ibrutinib treatment was 11.6 months (range, 1-62 months); median time from ibrutinib discontinuation to acalabrutinib start was 47 days (range, 3-331 days). After a median of 19.0 months (range, 0.2-30.6 months), 23 patients remained on acalabrutinib; 10 had discontinued (progressive disease, n = 4; AEs, n = 3). No acalabrutinib dose reductions occurred. During acalabrutinib treatment, the most frequent AEs included diarrhea (58%), headache (39%), and cough (33%). Grade 3/4 AEs occurred in 58%, most commonly neutropenia (12%) and thrombocytopenia (9%). Of 61 ibrutinib-related AEs associated with intolerance, 72% did not recur and 13% recurred at a lower grade with acalabrutinib. Overall response rate was 76%, including 1 complete and 19 partial responses and 5 partial responses with lymphocytosis. Among 25 responders, median duration of response was not reached. Median progression-free survival (PFS) was not reached; 1-year PFS was 83.4% (95% confidence interval, 64.5%-92.7%). Acalabrutinib was well tolerated with a high response rate in patients who were previously intolerant to ibrutinib. This trial was registered at www.clinicaltrials.gov as #NCT02029443.

Indexed as

AdenineAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overAntineoplastic AgentsBenzamidesDiarrheaDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPhosphorylationPiperidinesacalabrutinibAdenineAgammaglobulinaemia Tyrosine KinaseAntineoplastic AgentsBenzamidesBTK protein, humanibrutinibPiperidinesProtein Kinase InhibitorsPyrazinesPyrazolesPyrimidines

Identifiers

PMID31088809
PMCPMC6517672

What OpenQuestion holds

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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.