Evidence map›Paper›PMID 39234862›Full record

ArticleHaematologica2025

Safety and efficacy of acalabrutinib plus bendamustine and rituximab in patients with treatment-naïve or relapsed/refractory mantle cell lymphoma: phase Ib trial.

Tycel Phillips, Michael Wang, Tadeusz Robak, David Gallinson, Don Stevens, Krish Patel, Safaa Ramadan, Chuan-Chuan Wun, Wojciech Jurczak, Stephen D Smith

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Haematologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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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

10 authors.

Tycel PhillipsUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI. tphillips@coh.org.
Michael WangMD Anderson Cancer Center, University of Texas, Houston, TX.
Tadeusz RobakCopernicus Memorial Hospital, Medical University of Lodz, Lodz.
David GallinsonSummit Medical Group, Florham Park, NJ.
Don StevensNorton Cancer Institute, Louisville, KY.
Krish PatelSwedish Cancer Institute, Seattle, WA.
Safaa RamadanAstraZeneca, Cambridge.
Chuan-Chuan WunAstraZeneca, South San Francisco, CA.
Wojciech JurczakMaria Sklodowska-Curie National Research Institute of Oncology, Krakow.
Stephen D SmithUniversity of Washington/Fred Hutchinson Cancer Center, Seattle, WA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter, open-label, phase Ib study (ACE-LY-106) assessed the safety and efficacy of acalabrutinib, bendamustine, and rituximab (ABR) in treatment-naïve (TN) and relapsed or refractory (R/R) mantle cell lymphoma (MCL). Patients received acalabrutinib from cycle 1 until disease progression or treatment discontinuation, bendamustine on days 1 and 2 of each cycle for up to 6 cycles, and rituximab on day 1 of each cycle for 6 cycles, continuing every other cycle from cycle 8 for 12 additional doses (TN cohort). Eighteen patients enrolled in the TN cohort and 20 in the R/R cohort. Median duration of exposure to acalabrutinib was 34.0 and 14.6 months in the TN and R/R cohorts, respectively. No new safety risks were identified, and most adverse events (AE) were grades 1 or 2. Thirteen patients from the TN cohort (72.2%) and 17 patients from the R/R cohort (85.0%) reported grade 3-4 AE, most commonly neutropenia (TN: 38.9%; R/R: 50.0%). AE leading to death were pneumonitis (N=1, TN cohort), COVID-19, and cerebrospinal meningitis (N=1 each, R/R cohort). Overall response was 94.4% and 85.0% in the TN and R/R cohorts, respectively; complete response rates were 77.8% and 70.0%, respectively. After a median follow-up of 47.6 months, median progression-free survival (PFS) and overall survival (OS) were not reached in the TN cohort. After a median follow-up of 20.4 months, median PFS was 28.6 months and OS was not reached in the R/R cohort. Results indicate that ABR was safe and efficacious, supporting further study in patients with TN MCL.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLymphoma, Mantle-CellAdultAgedAged, 80 and overBendamustine HydrochlorideBenzamidesDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalPyrazinesRituximabTreatment OutcomeacalabrutinibBendamustine HydrochlorideBenzamidesPyrazinesRituximab

Identifiers

PMID39234862
PMCPMC11873691

What OpenQuestion holds

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LicenceCC BY-NC
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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.