^
    5d
    BRUIN CLL-322: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (clinicaltrials.gov)
    P3, N=600, Active, not recruiting, Loxo Oncology, Inc. | Trial primary completion date: Apr 2026 --> Oct 2026 | Trial completion date: Jan 2027 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Jaypirca (pirtobrutinib) • Truxima (rituximab-abbs)
    6d
    BTK Inhibition in Hematology: From CLL/SLL to Emerging Applications Across B-Cell and Immune Disorders. (PubMed, Biomolecules)
    Covalent BTK inhibitors (ibrutinib, acalabrutinib, and zanubrutinib) irreversibly bind the C481 residue and have produced high response rates and durable disease control, often replacing chemoimmunotherapy in the relapsed setting and, for some entities, even in the first line. Non-covalent BTK inhibitors (e.g., pirtobrutinib) bind BTK independently of C481, can overcome classic C481-mediated resistance, and extend BTK pathway targeting into later lines of therapy. Overall, BTK inhibition has evolved into a versatile platform enabling long-term, often chemo-free management strategies.
    Review • Journal • IO biomarker
    |
    PLCG2 (Phospholipase C Gamma 2)
    |
    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Jaypirca (pirtobrutinib)
    7d
    BRUIN: A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL (clinicaltrials.gov)
    P1/2, N=803, Completed, Loxo Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2027 --> Dec 2025
    Trial completion • Trial completion date
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Jaypirca (pirtobrutinib)
    12d
    BRUIN CLL-313: A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov)
    P3, N=309, Active, not recruiting, Loxo Oncology, Inc. | Trial completion date: Aug 2026 --> Oct 2027
    Trial completion date
    |
    Rituxan (rituximab) • Jaypirca (pirtobrutinib) • bendamustine • Truxima (rituximab-abbs)
    14d
    PRIME-PCNSL: A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort) (clinicaltrials.gov)
    P2, N=110, Recruiting, Tongji Hospital
    New P2 trial • Real-world evidence
    |
    Rituxan (rituximab) • Tyvyt (sintilimab) • cytarabine • Jaypirca (pirtobrutinib)
    19d
    ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL (clinicaltrials.gov)
    P3, N=306, Not yet recruiting, Newave Pharmaceutical Inc
    New P3 trial
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
    |
    TP53 mutation
    |
    Jaypirca (pirtobrutinib) • rocbrutinib (LP-168)
    27d
    EPCORE CLL-1: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (clinicaltrials.gov)
    P1/2, N=424, Recruiting, Genmab | Trial completion date: Aug 2029 --> Apr 2028 | Trial primary completion date: Jun 2029 --> Feb 2028
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp)
    2ms
    BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. (PubMed, J Clin Oncol)
    Pirtobrutinib demonstrated superiority over BendaR in IRC-assessed PFS in treatment-naïve CLL/SLL. OS trends favored pirtobrutinib despite the study design allowing for crossover. Pirtobrutinib was well tolerated, consistent with its known safety profile, and more favorable than BendaR.
    P3 data • Journal • IO biomarker
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    IGH mutation
    |
    Rituxan (rituximab) • Jaypirca (pirtobrutinib) • bendamustine
    2ms
    The Evolving Therapeutic Landscape of Richter Transformation. (PubMed, Curr Hematol Malig Rep)
    The combination of the B-cell lymphoma 2 inhibitor venetoclax with CIT has emerged as a new first-line benchmark with promising response rates and overall survival...Pirtobrutinib has demonstrated responses even in heavily pretreated patients...For R/R disease, novel BTK inhibitors, bispecific antibodies, and cellular therapies are demonstrating substantial efficacy. Ongoing trials investigating combinations of these agents are poised to further transform RT management.
    Review • Journal
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Jaypirca (pirtobrutinib)
    2ms
    Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL (clinicaltrials.gov)
    P2, N=29, Recruiting, The First Affiliated Hospital of Soochow University
    New P2 trial
    |
    Rituxan (rituximab) • Jaypirca (pirtobrutinib) • lisaftoclax (APG-2575)
    3ms
    A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) (clinicaltrials.gov)
    P2, N=40, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Jaypirca (pirtobrutinib)
    3ms
    GOlDiLOX: NHL37 - A phase I/II study to assess safety of combining Glofitamab and Pirtobrutinib (LOXo-305) for treatment in patients with Mantle Cell Lymphoma (MCL) and prior therapy with a BTK inhibitor. (ACTRN12622001275752)
    P1/2, N=48, Recruiting, Australasian Leukaemia and Lymphoma Group (ALLG) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jaypirca (pirtobrutinib) • Columvi (glofitamab-gxbm)