^
    1d
    STAIR: STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P2, N=160, Active, not recruiting, French Innovative Leukemia Organisation | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2026 --> Aug 2025
    Enrollment closed • Trial primary completion date
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    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
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    TP53 mutation • IGH mutation
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    Calquence (acalabrutinib)
    2d
    Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
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    Rituxan (rituximab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    3d
    ASSURE: Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (clinicaltrials.gov)
    P3, N=552, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion
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    TP53 (Tumor protein P53) • CD20 (Membrane Spanning 4-Domains A1) • IGH (Immunoglobulin Heavy Locus) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
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    Chr del(17p) • Chr del(11q) • IGH mutation
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    Calquence (acalabrutinib)
    3d
    RETAIN: Retention Rate of Acalabrutinib in a Non-interventional Setting (clinicaltrials.gov)
    P=N/A, N=137, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=200 --> 137
    Enrollment closed • Enrollment change
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    Calquence (acalabrutinib)
    8d
    Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
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    Calquence (acalabrutinib) • CD19 CAR T cells
    9d
    Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy (clinicaltrials.gov)
    P2, N=79, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Initiation date: Jun 2025 --> Dec 2025
    Trial initiation date
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    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Inokai (orelabrutinib)
    10d
    MRD-driven Initial Therapy of Acalabrutinib and Lenalidomide plus Rituximab (ALR) or Obinutuzumab (ALO) for Mantle Cell Lymphoma. (PubMed, Blood Adv)
    Longitudinal cfDNA analysis in ALR revealed clonal evolution during response and progression. This safe and active regimen is feasible as a time-limited initial therapy for MCL patients and warrants further evaluation in response-adapted strategy.
    Journal
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    TP53 (Tumor protein P53)
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    TP53 mutation
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    clonoSEQ
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    Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    15d
    ACE-CL-003: Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL (clinicaltrials.gov)
    P1, N=69, Completed, Acerta Pharma BV | Trial completion date: Sep 2027 --> Oct 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
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    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    18d
    Emerging first-line treatment approaches for mantle cell lymphoma. (PubMed, Leuk Lymphoma)
    In the front-line setting important recent developments include (1) approval of the BTK inhibitor (BTKi) acalabrutinib in combination with the chemoimmunotherapy, (2) evidence that the BTKi ibrutinib given with induction chemotherapies and during maintenance phase is highly effective, (3) BTKi without chemotherapy has produced promising results, (4) BCL2 inhibitor venetoclax and BTKi can be combined to effectively treat high risk MCL with TP53 alterations, and (5) consolidation with autologous stem cell transplant (ASCT) may not provide additional efficacy benefit for patients who have received highly effective first-line treatments but may be associated with substantial toxicities. These results support a concerted effort to bring BTKi to the first-line treatment of MCL. This review focuses on key clinical trials that provide the above insights and provides a succinct review of relevant historical regimens to guide oncologists in the management of untreated MCL.
    Review • Journal
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    TP53 (Tumor protein P53)
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    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Calquence (acalabrutinib)
    19d
    Identification of plasma cell infiltration-related gene signatures as a novel prognostic model for clear cell renal cell carcinoma. (PubMed, Clin Exp Med)
    Drug sensitivity analysis revealed that tyrosine kinase inhibitors (e.g., ceritinib, imatinib) potently inhibited cancer cell lines in the high PC score group, while inhibitors like acalabrutinib were effective in the low PC score group. Expression of hub genes in KIRC patients was validated using a local cohort and single-cell sequencing. We identified key genes regulating PC infiltration in KIRC and proposed a predictive model that effectively identifies high-risk KIRC patients.
    Journal • Gene Signature
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    CD8 (cluster of differentiation 8) • ADAM8 (ADAM Metallopeptidase Domain 8) • KCNN4 (Potassium Calcium-Activated Channel Subfamily N Member 4) • PPARGC1A (PPARG Coactivator 1 Alpha) • RAG1 (Recombination Activating 1) • TCIRG1 (T Cell Immune Regulator 1, ATPase H+ Transporting V0 Subunit A3)
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    imatinib • Zykadia (ceritinib) • Calquence (acalabrutinib)
    22d
    Acalabrutinib May Offer a New Therapeutic Approach for Consolidation and Maintenance of Primary CNS Lymphoma with Expression of MYD88 and CD79B Gene Variants: A Case Report and Literature Review of Primary CNS Lymphoma in the BTKi Era. (PubMed, Int J Mol Sci)
    This is the first reported case in the literature of acalabrutinib use for consolidation and maintenance of PCNSL. We hope this can support clinical trial design for BTKi use in this setting in the future.
    Journal
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    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD79B (CD79b Molecule)
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    Calquence (acalabrutinib)
    24d
    Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=24, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
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    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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    Calquence (acalabrutinib)