^
    14h
    Cardiotoxicities in Patients Receiving BTKi (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, Dana-Farber Cancer Institute | N=160 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Imbruvica (ibrutinib) • Calquence (acalabrutinib)
    14d
    Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO) (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, iOMEDICO AG | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    Calquence (acalabrutinib)
    14d
    ACE-LY-003: Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=113, Active, not recruiting, Acerta Pharma BV | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy
    |
    Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
    17d
    Acalabrutinib-based regimens in frontline or relapsed/refractory higher-risk CLL: Pooled analysis of 5 clinical trials. (PubMed, Blood Adv)
    To better understand the impact of the second-generation BTKi acalabrutinib, we pooled data from 5 prospective clinical studies of acalabrutinib as monotherapy or in combination with obinutuzumab (ACE-CL-001, ACE-CL-003, ELEVATE-TN, ELEVATE-RR, and ASCEND) in patients with higher-risk CLL in treatment-naive (TN) or relapsed/refractory (R/R) cohorts. The safety profile of acalabrutinib-based therapy in this population was consistent with the known safety profile of acalabrutinib in a broad CLL population. Our analysis demonstrates long-term benefit of acalabrutinib-based regimens in patients with higher-risk CLL, regardless of line of therapy.
    Retrospective data • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation • IGH mutation
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    19d
    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 | Recruiting --> Active, not recruiting | N=50 --> 32
    Enrollment closed • Enrollment change
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Venclexta (venetoclax) • Calquence (acalabrutinib)
    19d
    Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=40, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    20d
    A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. (clinicaltrials.gov)
    P3, N=344, Recruiting, Ascentage Pharma Group Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Rituxan (rituximab) • cyclophosphamide • Calquence (acalabrutinib) • Leukeran (chlorambucil) • lisaftoclax (APG-2575) • fludarabine IV
    21d
    MAJIC: A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P3, N=607, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    21d
    Acalabrutinib, venetoclax and obinutuzumab in relapsed CLL: Final efficacy and ctDNA analysis of the CLL2-BAAG trial. (PubMed, Blood)
    The phase 2 CLL2-BAAG trial tested the measurable residual disease (MRD)-guided triple combination of acalabrutinib, venetoclax and obinutuzumab after an optional bendamustine debulking in 45 patients with relapsed/refractory CLL (one patient was excluded from the analysis due to a violation of exclusion criteria). The addition of ctDNA-based analyses to FCM MRD assessment seems to improve early detection of relapses. ClinicalTrials.gov Identifier: NCT03787264.
    Journal • Circulating tumor DNA
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib) • bendamustine
    22d
    Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=15, Completed, SCRI Development Innovations, LLC | Active, not recruiting --> Completed | Trial completion date: Aug 2027 --> Apr 2024 | Trial primary completion date: Aug 2027 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 expression
    |
    Calquence (acalabrutinib)
    22d
    SAKK 38/19: Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial. (clinicaltrials.gov)
    P2, N=260, Recruiting, Swiss Group for Clinical Cancer Research | Trial primary completion date: Mar 2026 --> Oct 2025
    Trial primary completion date • Circulating tumor DNA
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib)
    25d
    ACALLO: Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT) (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Polish Lymphoma Research Group | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Jun 2024
    Enrollment closed • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Calquence (acalabrutinib)
    26d
    Development of combination therapies with BTK inhibitors and dasatinib to treat CNS-infiltrating E2A-PBX1+/preBCR+ ALL. (PubMed, Blood Adv)
    Moreover, combination of dasatinib with BTK inhibitors (BTKi) (ibrutinib, acalabrutinib or zanubrutinib) significantly decreased E2A-PBX1+/preBCR+ human and murine cell proliferation, reduced PLCG2 and BTK phosphorylation and total protein levels and increased disease-free survival of mice in secondary transplantation assays, reducing particularly CNS-leukemic infiltration. Hence, dasatinib with ibrutinib reduced pPLCG2 and pBTK in primary ALL patient samples, including E2A-PBX1+ ALLs. In summary, genetic depletion and pharmacological inhibition of BTK increase dasatinib effects in human and mouse E2A-PBX1+/preBCR+ ALL in most of performed assays, and the combination of dasatinib and BTKi is very effective in reducing CNS-infiltration of E2A-PBX1+/preBCR+ ALL cells in vivo.
    Journal • Combination therapy
    |
    PLCG2 (Phospholipase C Gamma 2) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1)
    |
    dasatinib • Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib)
    29d
    Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, City of Hope Medical Center | Initiation date: Mar 2024 --> Jun 2024
    Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    1m
    Combination of acalabrutinib with lenalidomide and rituximab in relapsed/refractory aggressive B-cell non-Hodgkin lymphoma: a single-arm phase II trial. (PubMed, Nat Commun)
    Overall, these results show a significant efficacy of the R2A regimen in patients with aggressive R/R B-cell NHL, with exploratory biomarkers suggesting potential associations with response. (ClinicalTrials.gov 51 identifier: NCT04094142).
    P2 data • Journal
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor)
    |
    MYD88 mutation
    |
    Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
    1m
    Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas (clinicaltrials.gov)
    P2, N=27, Recruiting, Patrick C. Johnson, MD | Not yet recruiting --> Recruiting | Trial completion date: Sep 2029 --> Mar 2029 | Trial primary completion date: Sep 2024 --> Mar 2025
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    cyclophosphamide • Calquence (acalabrutinib) • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    1m
    Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=24 --> 60
    Enrollment closed • Enrollment change
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
    1m
    PICAROS - Acalabrutinib RWE on 1L CLL in Spain (clinicaltrials.gov)
    P=N/A, N=193, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=315 --> 193
    Enrollment closed • Enrollment change • Real-world evidence • Real-world
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation + Chr del(17p)
    |
    Calquence (acalabrutinib)
    2ms
    A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. (clinicaltrials.gov)
    P3, N=344, Not yet recruiting, Ascentage Pharma Group Inc.
    New P3 trial • Combination therapy
    |
    Rituxan (rituximab) • cyclophosphamide • Calquence (acalabrutinib) • Leukeran (chlorambucil) • lisaftoclax (APG-2575) • fludarabine IV
    2ms
    ACE-CL-311: Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (clinicaltrials.gov)
    P3, N=984, Active, not recruiting, Acerta Pharma BV | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • IO biomarker
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • cyclophosphamide • Calquence (acalabrutinib)
    2ms
    ESCALADE: A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) (clinicaltrials.gov)
    P3, N=611, Active, not recruiting, Acerta Pharma BV | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • vincristine
    2ms
    The dual HCK/BTK inhibitor KIN-8194 impairs growth and integrin-mediated adhesion of BTKi-resistant mantle cell lymphoma. (PubMed, Leukemia)
    Here, we show that KIN-8194, a dual inhibitor of BTK and HCK with in vivo activity against Myd88-L265P-driven diffuse large B-cell lymphoma and Waldenström Macroglobulinemia, has a potent growth inhibitory effect in MCL cell lines and primary MCL cells, irrespective of their sensitivity to BTKi (ibrutinib and acalabrutinib). Taken together, our data demonstrate that KIN-8194 inhibits growth and integrin-mediated adhesion of BTKi-sensitive MCL cells, as well as MCL cells with primary or acquired BTKi resistance. This renders KIN-8194 a promising novel treatment for MCL patients.
    Journal
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • HCK (HCK Proto-Oncogene)
    |
    MYD88 L265P
    |
    Imbruvica (ibrutinib) • Calquence (acalabrutinib) • KIN-8194
    2ms
    RG1006269: Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=50, Recruiting, University of Washington | Trial completion date: Mar 2029 --> Mar 2030 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • CAR T-Cell Therapy
    |
    CD4 (CD4 Molecule)
    |
    Calquence (acalabrutinib) • Yescarta (axicabtagene ciloleucel)
    2ms
    Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, University of Rochester | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> May 2023
    Trial completion date • Trial primary completion date
    |
    Calquence (acalabrutinib) • Rituxan Hycela (rituximab/hyaluronidase)
    2ms
    Acalabrutinib in CNSL (clinicaltrials.gov)
    P1/2, N=49, Recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial primary completion date
    |
    Calquence (acalabrutinib)
    2ms
    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: Jan 2025 --> Oct 2025 | Trial primary completion date: Jan 2024 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Calquence (acalabrutinib)
    2ms
    Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | N=24 --> 35
    Enrollment change • Enrollment closed
    |
    clonoSEQ
    |
    Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
    3ms
    A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL (clinicaltrials.gov)
    P=N/A, N=89, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting --> Recruiting | Initiation date: Aug 2023 --> Jan 2024
    Enrollment open • Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    3ms
    KEYNOTE145: ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=161, Active, not recruiting, Acerta Pharma BV | Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2025 --> Apr 2026
    Phase classification • Trial completion date • Combination therapy
    |
    Keytruda (pembrolizumab) • Calquence (acalabrutinib)
    3ms
    Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
    Trial completion date • Trial primary completion date
    |
    Calquence (acalabrutinib)
    3ms
    ALTAMIRA: Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=81, Active, not recruiting, Nordic Lymphoma Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Rituxan (rituximab) • Calquence (acalabrutinib)
    3ms
    ACE-CL-003: Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL (clinicaltrials.gov)
    P1, N=69, Active, not recruiting, Acerta Pharma BV | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    3ms
    Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3, N=155, Active, not recruiting, AstraZeneca | Trial completion date: Jun 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • Calquence (acalabrutinib) • Leukeran (chlorambucil)
    3ms
    A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Acerta Pharma BV | Trial completion date: Jun 2023 --> Jun 2024
    Trial completion date • Combination therapy
    |
    Calquence (acalabrutinib) • ceralasertib (AZD6738)
    3ms
    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: Dec 2025 --> Sep 2026
    Trial completion date
    |
    Imbruvica (ibrutinib) • Calquence (acalabrutinib)
    3ms
    Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> Apr 2026
    Trial completion date • Combination therapy
    |
    Calquence (acalabrutinib) • ACP-319
    3ms
    ACE-LY-004: An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=124, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> Sep 2026
    Trial completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Calquence (acalabrutinib)
    4ms
    Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=50, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Venclexta (venetoclax) • Calquence (acalabrutinib)
    4ms
    Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=50, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Venclexta (venetoclax) • Calquence (acalabrutinib)
    4ms
    TrAVeRse: A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • PAX5 (Paired Box 5) • CD5 (CD5 Molecule)
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Calquence (acalabrutinib)
    4ms
    ACE-ST-209: A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, Acerta Pharma BV | Phase classification: P1b/2 --> P1/2
    Phase classification
    |
    Calquence (acalabrutinib)
    4ms
    Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, City of Hope Medical Center | Initiation date: Dec 2023 --> Mar 2024
    Trial initiation date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)