Evidence map›Paper›PMID 33730844›Full record

Trial reportHaematologica2021

Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia.

Kerry A Rogers, Philip A Thompson, John N Allan, Morton Coleman, Jeff P Sharman, Bruce D Cheson, Daniel Jones, Raquel Izumi, Melanie M Frigault, Cheng Quah and 4 more

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Haematologica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 4 pooled it
10.2field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 4 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. Review
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  14. Article
  15. Article
  16. Review
  17. Article
  18. Management of Relapsed and/or Refractory Chronic Lymphocytic Leukemia.Hematology/oncology clinics of North America · 2025
    Review
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 1 country.

Kerry A RogersThe Ohio State University, Columbus, OH. Kerry.Rogers@osumc.edu.
Philip A ThompsonMD Anderson Cancer Center, Houston, TX.
John N AllanWeill Cornell Medicine, New York, NY.
Morton ColemanWeill Cornell Medicine, New York, NY.
Jeff P SharmanWillamette Valley Cancer Institute, Eugene, OR.
Bruce D ChesonGeorgetown University Hospital, Washington, DC.
Daniel JonesThe Ohio State University, Columbus, OH.
Raquel IzumiAcerta Pharma, South San Francisco, CA.
Melanie M FrigaultAcerta Pharma, South San Francisco, CA.
Cheng QuahAcerta Pharma, South San Francisco, CA.
Rakesh K RamanAcerta Pharma, South San Francisco, CA.
Priti PatelAcerta Pharma, South San Francisco, CA.
Min Hui WangAcerta Pharma, South San Francisco, CA.
Thomas J KippsUC San Diego Moores Cancer Center, San Diego, CA.
The Ohio State University · USCornell University · USGeorgetown University · USMoores Cancer CenterThe University of Texas MD Anderson Cancer Center · USWeill Cornell Medicine · USWillamette Valley Cancer Institute and Research Center · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

B-cell receptor signalling inhibition by targeting Bruton tyrosine kinase (BTK) is effective in treating chronic lymphocytic leukemia (CLL). The BTK inhibitor ibrutinib may be intolerable for some patients. Acalabrutinib is a more selective BTK inhibitor that may be better tolerated by patients who are intolerant to ibrutinib. A phase 2 study of acalabrutinib was conducted in patients with relapsed/refractory CLL who were ibrutinib-intolerant and had continued disease activity. Intolerance was defined as having discontinued ibrutinib due to persistent grade 3/4 adverse events (AEs) or persistent/recurrent grade 2 AEs despite dose modification/interruption. Patients received oral acalabrutinib 100 mg twice daily until disease progression or intolerance. Sixty patients were treated. Overall response rate to acalabrutinib was 73% and three patients (5%) achieved complete remission. At median follow-up of 35 months, the median progressionfree and overall survival were not reached; 24-month estimates were 72% and 81%, respectively. The most frequent AEs with acalabrutinib were diarrhea (53%), headache (42%), contusion (40%), dizziness (33%), upper respiratory tract infection (33%), and cough (30%). Most common reasons for acalabrutinib discontinuation were progressive disease (23%) and AEs (17%). Most patients with baseline samples (49/52; 94%) and all with on-treatment samples (3/3; 100%) had no detectable BTK and/or PLCG2 mutations. Acalabrutinib is effective and tolerable in most patients with relapsed/refractory CLL who are intolerant of ibrutinib. Acalabrutinib may be useful for patients who may benefit from BTK inhibitor therapy but are ibrutinib intolerant.

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellAdenineBenzamidesHumansPiperidinesProtein Kinase InhibitorsPyrazinesacalabrutinibAdenineBenzamidesibrutinibPiperidinesProtein Kinase InhibitorsPyrazines

Identifiers

PMID33730844
PMCPMC8409022
OpenAlexW3138884962

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.