Trial reportBlood2023
Detailed safety profile of acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia in the ELEVATE-RR trial.
Trial report in Blood, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02477696 (A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib), which is not on this map. Cited by 78 papers, 3 of them syntheses that pooled 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.
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.
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
Who cites it
78 citing papers in PubMed, 3 syntheses or guidelines pooled it, 107 citations in OpenAlex.
- Invasive fungal infections after Bruton tyrosine kinase inhibitor treatment: a systematic review and meta-analysis.Blood advances · 2026Pooled it
- Cardiac safety profiles of first-generation vs second-generation BTK inhibitors: a meta-analysis.The oncologist · 2026Pooled it
- Efficacy and safety of first- versus second-generation Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: a systematic review and meta-analysis.Frontiers in pharmacology · 2024Pooled it
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- Long-term follow-up of MRD-guided ibrutinib plus venetoclax in relapsed CLL: phase 2 VISION/HO141 trial.Blood advances · 2025Trial
- Bruton's Tyrosine Kinase Inhibitors: Mechanisms, Efficacy, Toxicities and Applications for the Treatment of Human Diseases.MedComm · 2026Review
- Safety and Management of Targeted Therapies for Relapsed/Refractory Chronic Lymphocytic Leukemia.Drug safety · 2026Review
- Mechanisms of resistance to BTK inhibitors in B cell malignancies and emerging targeted strategies.Molecular therapy. Oncology · 2026Review
- Review
- Older patients with lymphoma: navigating a landscape of clinical controversies and barriers to innovation.Haematologica · 2026Review
- Real-world effectiveness and safety of acalabrutinib in chronic lymphocytic leukaemia: Multicentre experience.British journal of haematology · 2026Observational
- Cardiovascular Toxicity of BTK Inhibitors: A Patient-Centered Framework for Risk Stratification and Management.Journal of clinical medicine · 2026Review
- Comparative Cardiovascular Safety and Exploratory Bleeding Outcomes of Ibrutinib, Acalabrutinib, and Zanubrutinib in Mantle Cell Lymphoma: A Propensity Score-Matched Real-World Analysis.Cancer medicine · 2026Article
- Outcomes of patients with chronic lymphocytic leukemia discontinuing covalent Bruton tyrosine kinase inhibitors due to adverse events.Leukemia · 2026Article
- Australasian chronic lymphocytic leukaemia consensus statement: 2026 update.Internal medicine journal · 2026Article
- Acalabrutinib monotherapy as a first-line treatment for CLL: 3-year follow-up of the real-world EPIC study.Blood advances · 2026Article
- First-Line Bruton's Tyrosine Kinase Inhibitor-Based Regimens for Mantle Cell Lymphoma.Current oncology (Toronto, Ont.) · 2026Review
- Cardiotoxicity of Targeted Therapies in Hematologic Malignancies: From Molecular Mechanisms to Clinical Management.Current treatment options in oncology · 2026Review
18 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
18 authors at 15 institutions in 8 countries.
Funding
Abstract
ELEVATE-RR demonstrated noninferior progression-free survival and lower incidence of key adverse events (AEs) with acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia. We further characterize AEs of acalabrutinib and ibrutinib via post hoc analysis. Overall and exposure-adjusted incidence rate was assessed for common Bruton tyrosine kinase inhibitor-associated AEs and for selected events of clinical interest (ECIs). AE burden scores based on previously published methodology were calculated for AEs overall and selected ECIs. Safety analyses included 529 patients (acalabrutinib, n = 266; ibrutinib, n = 263). Among common AEs, incidences of any-grade diarrhea, arthralgia, urinary tract infection, back pain, muscle spasms, and dyspepsia were higher with ibrutinib, with 1.5- to 4.1-fold higher exposure-adjusted incidence rates. Incidences of headache and cough were higher with acalabrutinib, with 1.6- and 1.2-fold higher exposure-adjusted incidence rate, respectively. Among ECIs, incidences of any-grade atrial fibrillation/flutter, hypertension, and bleeding were higher with ibrutinib, as were exposure-adjusted incidence rates (2.0-, 2.8-, and 1.6-fold, respectively); incidences of cardiac events overall (the Medical Dictionary for Regulatory Activities system organ class) and infections were similar between arms. Rate of discontinuation because of AEs was lower for acalabrutinib (hazard ratio, 0.62; 95% confidence interval, 0.41-0.93). AE burden score was higher for ibrutinib vs acalabrutinib overall and for the ECIs atrial fibrillation/flutter, hypertension, and bleeding. A limitation of this analysis is its open-label study design, which may influence the reporting of more subjective AEs. Overall, event-based analyses and AE burden scores demonstrated higher AE burden overall and specifically for atrial fibrillation, hypertension, and hemorrhage with ibrutinib vs acalabrutinib. This trial was registered at www.clinicaltrials.gov as #NCT02477696.
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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.