^
    7d
    The Care and Cure of the Leukemias in 2026. (PubMed, Am J Hematol)
    Currently, most leukemias are effectively treated with immunotherapies (highly effective monoclonal antibodies targeting CD19 [blinatumomab], or CD22 [inotuzumab ozogamicin]), BCR::ABL1 tyrosine kinase inhibitors (TKIs; e.g., dasatinib, ponatinib), Bruton TKIs (e.g., ibrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax), IDH1/2 inhibitors (ivosidenib, olutasidenib, and enasidenib), FLT3 inhibitors (e.g., midostaurin, quizartinib, and gilteritinib), menin inhibitors (revumenib, ziftomenib), and chimeric antigen receptor T-cell therapies. Herein, we provide a high-level overview of prominent clinical developments across all leukemias. In contemporary times, harnessing the benefits of novel targeted therapies and the evolving treatment landscape bolster the optimistic view that most, if not all, leukemias are curable.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
    |
    TP53 mutation • KMT2A mutation • MLL mutation
    |
    Venclexta (venetoclax) • dasatinib • Imbruvica (ibrutinib) • Iclusig (ponatinib) • Xospata (gilteritinib) • Blincyto (blinatumomab) • midostaurin • Calquence (acalabrutinib) • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Besponsa (inotuzumab ozogamicin) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib) • Rezlidhia (olutasidenib)
    11d
    MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma. (PubMed, Blood Adv)
    This safe and active regimen is feasible as a time-limited initial therapy for patients with MCL and warrants further evaluation in response-adapted strategy. This trial was registered at www.ClinicalTrials.gov as NCT03863184.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    clonoSEQ
    |
    Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    11d
    BGB-11417-304: 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, Recruiting, BeOne Medicines | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • sonrotoclax (BGB-11417)
    11d
    ALICIA(BY): Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Calquence (acalabrutinib)
    14d
    Acalabrutinib in CNSL (clinicaltrials.gov)
    P1/2, N=49, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Calquence (acalabrutinib)
    16d
    Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
    P=N/A, N=67, Completed, AstraZeneca | Trial completion date: May 2026 --> Aug 2025 | Trial primary completion date: May 2026 --> Aug 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    Calquence (acalabrutinib)
    16d
    Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P2, N=52, Recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Oct 2026 | Trial primary completion date: Dec 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    17d
    CLL16: A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) (2023-506414-46-00)
    P2/3, N=232, Recruiting, University Of Cologne
    New P2/3 trial
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    17d
    ACE-LY-308: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL (clinicaltrials.gov)
    P3, N=635, Active, not recruiting, Acerta Pharma BV | Trial completion date: Oct 2025 --> Feb 2027 | Trial primary completion date: Oct 2025 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • PAX5 (Paired Box 5) • CD5 (CD5 Molecule)
    |
    Chr t(11;14)
    |
    Calquence (acalabrutinib) • bendamustine • Rituxan Hycela (rituximab/hyaluronidase)
    17d
    Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2026 --> Feb 2028 | Trial primary completion date: Feb 2026 --> Feb 2028
    Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14)
    |
    Venclexta (venetoclax) • Calquence (acalabrutinib)
    23d
    Inhibition of acalabrutinib metabolism by finerenone and its molecular docking studies. (PubMed, Cell Biol Toxicol)
    Finally, acalabrutinib and finerenone were evaluated for binding to cytochrome P450 3A4 (CYP3A4) by molecular docking, yielding binding energies of -2.36 and -2.19 kcal/mol, respectively. Thus, in vivo and in vitro results consistently indicated that finerenone inhibited the metabolism of acalabrutinib, providing the basis for individualized dosing considerations.
    Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Calquence (acalabrutinib)
    25d
    Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P2, N=49, Recruiting, Emory University | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib)