^
    8d
    A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma (clinicaltrials.gov)
    P3, N=3, Completed, Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting --> Completed | N=356 --> 3 | Trial completion date: Dec 2027 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Inokai (orelabrutinib)
    9d
    Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation (clinicaltrials.gov)
    P2, N=35, Recruiting, The First Affiliated Hospital of Soochow University
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    cyclophosphamide • Inokai (orelabrutinib) • Polivy (polatuzumab vedotin-piiq)
    15d
    MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL (clinicaltrials.gov)
    P2, N=145, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    lenalidomide • Gazyva (obinutuzumab) • Inokai (orelabrutinib)
    19d
    A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis (clinicaltrials.gov)
    P3, N=990, Recruiting, Zenas BioPharma (USA), LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Inokai (orelabrutinib)
    21d
    Treatment of BTKi+Hi-CVP Regimen for Previously Untreated MZL (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    cyclophosphamide • vincristine • Inokai (orelabrutinib) • Anruixi (zuberitamab)
    23d
    Efficacy and safety analysis of BTK inhibitors combined with R-CHOP regimen in newly diagnosed double-expressor diffuse large B-cell lymphoma (PubMed, Zhonghua Xue Ye Xue Za Zhi)
    Among them, 35 patients received BTKi (zanubrutinib, orelabrutinib, acalabrutinib) combined with R-CHOP (BTKi + R-CHOP group) , and 60 received R-CHOP regimen alone (R-CHOP group) . Grade ≥ 3 adverse events primarily included neutropenia (28.6% ) and pulmonary infection (14.3% ) ; no fatal bleeding or cardiovascular events occurred. BTKi combined with R-CHOP significantly improved response rates and survival in patients with DE-DLBCL, with manageable safety.
    Retrospective data • Journal • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    Rituxan (rituximab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Inokai (orelabrutinib)
    1m
    Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL (clinicaltrials.gov)
    P2, N=50, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • lenalidomide • Inokai (orelabrutinib)
    1m
    MZL-IIT-O: Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL (clinicaltrials.gov)
    P2, N=30, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    Inokai (orelabrutinib)
    1m
    Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting | Trial completion date: Sep 2028 --> Sep 2027 | Trial primary completion date: Sep 2027 --> Aug 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Inokai (orelabrutinib)
    2ms
    PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. (clinicaltrials.gov)
    P2, N=50, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    Rituxan (rituximab) • Inokai (orelabrutinib)
    2ms
    A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P3, N=394, Recruiting, Guangzhou Lupeng Pharmaceutical Company LTD.
    New P3 trial
    |
    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Inokai (orelabrutinib) • rocbrutinib (LP-168)
    2ms
    Bendamustine combined with Zuberitamab (BZ) followed by Orelabrutinib combined with Zuberitamab (OZ) in the treatment of newly diagnosed marginal zone lymphoma:A Phase II prospective clinical study (ChiCTR2500115104)
    P=N/A, N=74, Not yet recruiting, The First Affiliated Hospital of the Air Force Medical University; The First Affiliated Hospital of the Air Force Medical University
    New trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Inokai (orelabrutinib) • bendamustine • Anruixi (zuberitamab)