^
    11d
    15-H-0016: Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL (clinicaltrials.gov)
    P2, N=48, Completed, Acerta Pharma BV | Active, not recruiting --> Completed | Trial completion date: Apr 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Calquence (acalabrutinib)
    11d
    First-line treatment for CLL in the era of targeted therapy. (PubMed, Blood Cancer J)
    The primary first-line treatment options for CLL comprise continuous therapies based on the BTK inhibitors ibrutinib, zanubrutinib, or acalabrutinib, or fixed-duration regimens combining the BCL2 inhibitor venetoclax with obinutuzumab or the BTK inhibitors ibrutinib or acalabrutinib (with or without obinutuzumab). Selecting the appropriate targeted therapy requires careful evaluation of a multitude of factors, including molecular disease features (especially del[17p]/TP53 and IGHV mutational status), comorbidities, comedications, and the patient's preferences. Focusing on primary treatment options, we review data from the key controlled trials that support the first-line use of targeted therapies for patients with CLL, consider ongoing trials that may support clinical decision-making in the future, and assess the potential to personalize treatment regimens in CLL based on minimal residual disease status.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation • IGH mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
    11d
    ACE-CL-208: A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Acerta Pharma BV | Trial completion date: Sep 2026 --> Jun 2026
    Trial completion date
    |
    Imbruvica (ibrutinib) • Calquence (acalabrutinib)
    13d
    ESR-23-22182: Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL (clinicaltrials.gov)
    P2, N=62, Recruiting, Zulfa Omer | Not yet recruiting --> Recruiting | Initiation date: Jun 2025 --> Dec 2025
    Enrollment open • Trial initiation date
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • SF3B1 (Splicing Factor 3b Subunit 1) • CD79B (CD79b Molecule) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • BIRC3 (Baculoviral IAP repeat containing 3) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • H1-4 (H1.4 Linker Histone, Cluster Member) • NFKBIE (NFKB Inhibitor Epsilon) • ZMYM3 (Zinc Finger MYM-Type Containing 3) • CHD2 (Chromodomain Helicase DNA Binding Protein 2) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr del(11q)
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Calquence (acalabrutinib)
    15d
    Lights and shades of front-line treatment with covalent BTK inhibitors combined with venetoclax in patients with chronic lymphocytic leukemia. (PubMed, Oncol Rev)
    The cBTKi + V regimen is easy to manage and relatively well tolerated. However, cBTKi-related cardiovascular toxicities remain a limiting concern, especially for the use of cBTKi + V in some older patients.
    Review • Journal
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
    1m
    BGB-3111-215t: Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, BeiGene | Trial completion date: Oct 2025 --> Dec 2025 | Trial primary completion date: Oct 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
    1m
    ALICIA(BY): Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, AstraZeneca
    New trial
    |
    Calquence (acalabrutinib)
    1m
    Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies (clinicaltrials.gov)
    P=N/A, N=15000, Not yet recruiting, University Hospital, Caen
    New trial
    |
    Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
    1m
    A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, BeOne Medicines
    New P3 trial
    |
    Venclexta (venetoclax) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • sonrotoclax (BGB-11417)
    1m
    KEYNOTE145: ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=161, Completed, Acerta Pharma BV | Active, not recruiting --> Completed | Trial completion date: Apr 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    Keytruda (pembrolizumab) • Calquence (acalabrutinib)
    1m
    Is Bruton tyrosine kinase a potential target to treat mast cell neoplasms? Systemic mastocytosis associated with chronic lymphoid leukemia successfully treated with acalabrutinib monotherapy: a case report and review of the literature. (PubMed, Haematologica)
    Not available.
    Journal
    |
    BTK (Bruton Tyrosine Kinase)
    |
    Calquence (acalabrutinib)
    1m
    Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=40, Completed, Acerta Pharma BV | Active, not recruiting --> Completed | Trial completion date: Apr 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    Calquence (acalabrutinib) • ACP-319