Evidence map›Paper›PMID 35861370›Full record

Trial reportBritish journal of haematology2022

A phase 2, multicentre, open-label trial (ACE-LY-003) of acalabrutinib in patients with relapsed or refractory marginal zone lymphoma.

Paolo Strati, Morton Coleman, Rebecca Champion, Shuo Ma, Caterina Patti, Moshe Y Levy, Izidore S Lossos, Praveen Ramakrishnan Geethakumari, Selay Lam, Roser Calvo and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report 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 trial NCT02180711 (An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.3field-weighted citation impact, top 5% 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.

NCT02180711 phase1 / phase2active not recruitingnot on this map

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

TypeinterventionalSponsorAcerta Pharma BVRan2014 to 2028Enrolled113ConditionsNon Hodgkin LymphomaArmsacalabrutinib, rituximab (IV), Lenalidomide
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
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  6. Review
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  12. New Means and Challenges in the Targeting of BTK.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Review
  13. B-cell non-Hodgkin lymphomas.Lancet (London, England) · 2024
    Review
  14. Review
  15. Review
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  18. Article
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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

12 authors at 11 institutions in 3 countries.

Paolo StratiThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0002-7445-1459
Morton ColemanClinical Research Alliance/Weill Cornell Medicine, New York, New York, USA.
Rebecca ChampionNorton Cancer Institute, Louisville, Kentucky, USA.
Shuo MaRobert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, USA.
Caterina PattiA.O.O.R. Villa Sofia-Cervello, U. O. C. Oncoematologia, Palermo, Italy.
Moshe Y LevyBaylor University Medical Center, Dallas, Texas, USA.
Izidore S LossosUniversity of Miami-Miller School of Medicine, Miami, Florida, USA.ORCID 0000-0002-9346-9013
Praveen Ramakrishnan GeethakumariHarold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Selay LamLondon Health Sciences Centre, London, Ontario, Canada.
Roser CalvoAstraZeneca, Gaithersburg, Maryland, USA.
Kara HigginsAstraZeneca, South San Francisco, California, USA.
Lihua E BuddeCity Of Hope National Medical Center, Duarte, California, USA.ORCID 0000-0003-1464-5494
AstraZeneca (United States) · USBaylor University Medical Center · USCity Of Hope National Medical Center · USCornell University · USLondon Health Sciences Centre · CANorthwestern University · USNorton Healthcare · USOspedale Vincenzo Cervello · ITThe University of Texas MD Anderson Cancer Center · USThe University of Texas Southwestern Medical Center · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acalabrutinib, a Bruton tyrosine kinase inhibitor, demonstrated greater selectivity and improved safety versus ibrutinib in a head-to-head trial in relapsed/refractory (R/R) chronic lymphocytic leukaemia. In the R/R marginal zone lymphoma (MZL) cohort (phase 2) of a phase 1b/2 trial (NCT02180711), 43 patients with MZL and at least one prior therapy received acalabrutinib 100 mg twice daily until disease progression or unacceptable toxicity [median age 69 years (range 42-84); median one (1-4) prior systemic regimens]. Median follow-up was 13.3 months (range 0.5-45.5). Among 40 patients evaluable for response, investigator-assessed overall response rate was 53% [95% confidence interval (CI) 36%-69%] with five (13%) complete responses. Tumour reduction occurred in 40 (93%) of the treated patients. Median time to response was 2.9 months (median duration of response not estimable). Estimated median progression-free survival (PFS) was 27.4 months (12-month PFS rate, 67%). Five patients died (disease progression, n = 4; septic shock, n = 1). Seventeen patients (40%) had grade 3 or higher adverse events (AEs), most commonly neutropenia (14%), anaemia, dyspnoea (7% each), fatigue and thrombocytopenia (5% each). Hypertension occurred in 5%; atrial fibrillation/flutter and major haemorrhage were not reported. AEs led to treatment discontinuation in three (7%) patients. Acalabrutinib was active and well tolerated in patients with R/R MZL.

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneAdultAgedAged, 80 and overBenzamidesDisease ProgressionHumansMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsPyrazinesTreatment OutcomeacalabrutinibBenzamidesProtein Kinase InhibitorsPyrazinesB-cell lymphomaBruton tyrosine kinasenon-Hodgkin lymphoma

Identifiers

PMID35861370
PMCPMC9796553
OpenAlexW4286491901

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.