^
    22d
    A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, Ruijin Hospital
    New P2 trial
    |
    bortezomib • Gazyva (obinutuzumab) • Yinuokai (orelabrutinib) • Columvi (glofitamab-gxbm)
    28d
    ORMD2021: A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Huashan Hospital | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date • Combination therapy
    |
    Rituxan (rituximab) • Yinuokai (orelabrutinib)
    28d
    Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial） (clinicaltrials.gov)
    P2, N=39, Recruiting, Sun Yat-sen University
    New P2 trial • Combination therapy
    |
    CD5 (CD5 Molecule)
    |
    CD5 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Yinuokai (orelabrutinib)
    28d
    Efficacy and safety analysis of the OR-CHOP regimen for the treatment of MCD subtype diffuse large B cell lymphoma in the real-world setting (PubMed, Zhonghua Xue Ye Xue Za Zhi)
    Objective: To investigate the efficacy and safety of orelabrutinib combined with R-CHOP in the treatment of MCD subtype diffuse large B cell lymphoma (DLBCL)...All patients were treated with R-CHOP or R-miniCHOP in Course 1, OR-CHOP or OR-miniCHOP (21 days for one course) in Courses 2-6, and R-monotherapy in Courses 7-8...Furthermore, the OR-CHOP regimen was generally well tolerated during clinical use, with hematological toxicity being the main adverse effect. This study revealed that the OR-CHOP regimen can be used as an effective and safe first-line treatment for MCD subtype DLBCL.
    Retrospective data • Journal • Real-world evidence • Real-world
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • ETV6 (ETS Variant Transcription Factor 6) • KMT2D (Lysine Methyltransferase 2D) • CD79B (CD79b Molecule) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • PIM1 (Pim-1 Proto-Oncogene) • CD58 (CD58 Molecule) • H1-4 (H1.4 Linker Histone, Cluster Member) • BTG2 (BTG Anti-Proliferation Factor 2)
    |
    Rituxan (rituximab) • vincristine • Yinuokai (orelabrutinib)
    2ms
    Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma (clinicaltrials.gov)
    P2, N=50, Recruiting, Fudan University
    New P2 trial
    |
    Yinuokai (orelabrutinib)
    3ms
    Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma (clinicaltrials.gov)
    P2, N=51, Recruiting, Huai'an First People's Hospital
    New P2 trial
    |
    Gazyva (obinutuzumab) • Yinuokai (orelabrutinib)
    3ms
    ICP-CL-01203: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2/3, N=226, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Yinuokai (orelabrutinib)
    4ms
    First-line Treatment of PCNSL With the Combination of Orelabrutinib, Rituximab, and Methotrexate (ORM Regimen) (clinicaltrials.gov)
    P2, N=22, Completed, Ningbo No. 1 Hospital | Recruiting --> Completed | Trial completion date: Jun 2027 --> Jul 2024
    Trial completion • Trial completion date
    |
    Rituxan (rituximab) • Yinuokai (orelabrutinib)
    4ms
    A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL (clinicaltrials.gov)
    P2, N=528, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide) • Yinuokai (orelabrutinib) • Anniko (penpulimab) • Polivy (polatuzumab vedotin-piiq)
    4ms
    Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas (clinicaltrials.gov)
    P2, N=45, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    Gazyva (obinutuzumab) • Yinuokai (orelabrutinib)
    4ms
    Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL) (clinicaltrials.gov)
    P2, N=73, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Yinuokai (orelabrutinib) • bendamustine
    4ms
    Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P2, N=186, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Phase classification: P2b --> P2 | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2024 --> Aug 2025
    Phase classification • Trial completion date • Trial primary completion date
    |
    Yinuokai (orelabrutinib)
    4ms
    The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy (clinicaltrials.gov)
    P2, N=50, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P2 trial
    |
    Yinuokai (orelabrutinib)
    4ms
    Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment (clinicaltrials.gov)
    P3, N=78, Recruiting, Ruijin Hospital
    New P3 trial • Combination therapy
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Yinuokai (orelabrutinib) • bendamustine
    5ms
    Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma. (clinicaltrials.gov)
    P2, N=45, Recruiting, Peking Union Medical College Hospital
    New P2 trial
    |
    lenalidomide • Gazyva (obinutuzumab) • Yinuokai (orelabrutinib)
    6ms
    A Study of ICP-022 in Patients With R/R DLBCL (clinicaltrials.gov)
    P2, N=3, Completed, Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting --> Completed | N=85 --> 3
    Trial completion • Enrollment change
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD79B (CD79b Molecule)
    |
    MYD88 L265P
    |
    Yinuokai (orelabrutinib)
    7ms
    ICP-CL-01203: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2/3, N=226, Not yet recruiting, Beijing InnoCare Pharma Tech Co., Ltd.
    New P2/3 trial • Combination therapy
    |
    Yinuokai (orelabrutinib)
    7ms
    ICP-CL-00105: A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (clinicaltrials.gov)
    P2, N=47, Completed, Beijing InnoCare Pharma Tech Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    Yinuokai (orelabrutinib)
    7ms
    A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL) (clinicaltrials.gov)
    P2, N=111, Completed, Beijing InnoCare Pharma Tech Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    Yinuokai (orelabrutinib)
    7ms
    A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL (clinicaltrials.gov)
    P3, N=490, Not yet recruiting, InnoCare Pharma Inc.
    New P3 trial • Combination therapy
    |
    Rituxan (rituximab) • Yinuokai (orelabrutinib) • bendamustine
    9ms
    Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI (clinicaltrials.gov)
    P2, N=62, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    cyclophosphamide • Yinuokai (orelabrutinib)
    9ms
    Chidamide and orelabrutinib synergistically induce cell cycle arrest and apoptosis in diffuse large B-cell lymphoma by regulating the PI3K/AKT/mTOR pathway. (PubMed, J Cancer Res Clin Oncol)
    The findings of this study provide a compelling justification for the clinical utilization of chidamide and orelabrutinib to treat relapsed/refractory DLBCL.
    Journal
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • HDAC2 (Histone deacetylase 2) • HDAC10 (Histone Deacetylase 10) • HDAC3 (Histone Deacetylase 3)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide) • Yinuokai (orelabrutinib)
    10ms
    Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma (clinicaltrials.gov)
    P2, N=160, Recruiting, Fudan University
    New P2 trial
    |
    Yinuokai (orelabrutinib)
    10ms
    Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov)
    P3, N=195, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yinuokai (orelabrutinib)
    10ms
    Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma (clinicaltrials.gov)
    P3, N=324, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • lenalidomide • Yinuokai (orelabrutinib)
    12ms
    Effectivness and Safety of Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Retrospective, Real-World Study in China (ASH 2023)
    This real-world study assessed the preliminary characteristics and clinical outcome of patients receiving orelabrutinib-containing regimens under routine clinical practice conditions in China. The orelabrutinib-containing regimens in this study furnished beneficial evidence for the treatment of CLL/SLL and is essential for determining the best treatment option, future data with a larger sample and longer follow-up will be updated.
    Retrospective data • Real-world evidence • Real-world
    |
    TP53 (Tumor protein P53)
    |
    Yinuokai (orelabrutinib)
    12ms
    Orelabrutinib Plus R-CHOP Regimen in Treatment-Naïve Patients with TP53-Mutated Diffuse Large B-Cell Lymphoma (DLBCL) (ASH 2023)
    Background: TP53-mutated DLBCL may be refractory to rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)...Of 7 pts, 5 pts received OR-CHOP, 2 OR-CHOP plus lenalidomide... These data supported that OR-CHOP-based regimens had favorable anti-tumor activity and manageable safety profile in pts with TP53-mutated DLBCL. BTKi related off-target AEs were rarely observed. More prospective studies are warranted to validate our findings.
    Clinical
    |
    TP53 (Tumor protein P53) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD79B (CD79b Molecule)
    |
    TP53 mutation • CD79B mutation • CD79B mutation
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Yinuokai (orelabrutinib)
    12ms
    Preliminary Outcomes of Orelabrutinib Plus R-CHOP in Treatment-Naive Patients with Double-Expression Diffuse Large B-Cell Lymphoma (ASH 2023)
    The Phoenix study demonstrated that ibrutinib (first generation of BTK inhibitor) plus R-CHOP could improve event-free survival (EFS) and overall survival (OS) in younger patients with DEL...They received 150 mg of orelabrutinib once daily on days 1-14 combined with R-CHOP (Rituximab 375 mg/m 2, cyclophosphamide 750 mg/m 2, liposome doxorubicin 30 mg/m 2, vincristine 1. 4 mg on day 1, and prednisone 100 mg daily on days 1-5)...ConclusionThe combination of orelabrutinib and RCHOP showed encouraging efficacy and a tolerable safety profile in DEL DLBCL in this preliminary analysis. More updated data from this ongoing study will be provided in the future.
    Clinical • IO biomarker
    |
    TP53 (Tumor protein P53) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    TP53 mutation • BCL2 expression • MYC expression
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • cyclophosphamide • vincristine • prednisone • Yinuokai (orelabrutinib)
    12ms
    Methotrexate in Combination with Orelabrutinib, Thiotepa, and Rituximab (R-MTO) Followed By Autologous Stem-Cell Transplant for Primary Central Nervous System Lymphoma Treatment (ASH 2023)
    The HCT regimen involved busulfan 3. 2 mg/kg on days -5, -4, thiotepa 250 mg/m 2 on days -7 and -6, cytarabine 2g/m 2 q12h on days -3 and -2, followed by reinfusion of stem cells on day 0... The R-MTO induction treatment has demonstrated notable efficacy in achieving higher response rates among patients with PCNSL, and the associated adverse events are manageable.
    Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Rituxan (rituximab) • cytarabine • methotrexate • Yinuokai (orelabrutinib) • thiotepa • busulfan • methotrexate IV
    12ms
    Pomalidomide, Rituximab, Orelabrutinib, and Minichop-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large-B Cell Lymphoma: Preliminary Results from a Phase II Study (ASH 2023)
    The Smart Start study demonstrated that induction therapy with rituximab (R), lenalidomide, and ibrutinib resulted in a high overall response rate (ORR) in patients with newly diagnosed DLBCL (Westin J, et al...Subsequently, patients who achieved at least mini response (miniR, a reduction in tumor lesions by 25%-50%) were administered additional 6 cycles of PRO-miniCHOP regimen (PRO with reduced-dose CHOP regimen [cyclophosphamide, 400 mg/m 2, d2; doxorubicin/liposomal doxorubicin, 25 mg/m 2/15 mg/m 2, d2; vindesine, 2 mg, d2; and dexamethasone, 7... The present study provided preliminary evidence supporting the use of the PRO-miniCHOP regimen in elderly patients with newly diagnosed DLBCL. More clinical data will be updated from this ongoing study.
    Clinical • P2 data • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    BCL2 expression • MYC expression
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • cyclophosphamide • Yinuokai (orelabrutinib) • dexamethasone • pomalidomide • vindesine
    12ms
    Orelabrutinib combined with rituximab for the treatment of elderly patients with newly diagnosed non-GCB diffuse large B-Cell lymphoma under the guidance of genetic subtype: A prospective , multicenter, single-arm, response-adaptive clinical study (Origin) (ChiCTR2300077256 )
    P4, N=63, Recruiting, The First Affiliated Hospital of Zhejiang University Medical College
    New P4 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • Yinuokai (orelabrutinib)
    1year
    A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen (clinicaltrials.gov)
    P=N/A, N=80, Active, not recruiting, Huashan Hospital
    New trial • Combination therapy
    |
    Yinuokai (orelabrutinib)
    1year
    A Single Center Real World Study of Outcome and Resistance of Bruton Tyrosine Kinase Inhibitors (BTKi) in Chinese Patients with Chronic Lymphocytic Leukeima/Small Lymphocytic Lymphoma (ASH 2023)
    Ibrutinib, Zanubrutinib, Orelabrutinib were administered in 55.3%,18.3% and 17.9% of patients respectively, in addition to 6 patients with Acalabrutinib and one with Loxo-305, among them 47.7% (125/262) received BTKi as first line treatment...Venetoclax-based regimen might be an effective salvage therapy which could showed a benefit trend in PFS as compared to other post BTKi therapy (10.1 months vs 3.1 months, p= 0.1818)...Acquired BTK/PLCG2 mutations remained to be key drivers of BTKis resistance and BTKC481S mutation was the dominant mutation, while BTKT474 mutation was only detected in Orelabrutinib-resistant patients. The prognosis was rather poor for relapsed patients especially for RTs, treatment strategy after disease progression remains to be optimized.
    Clinical • Real-world evidence • Real-world
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus) • PLCG2 (Phospholipase C Gamma 2)
    |
    TP53 mutation • LDH elevation • Chr del(11q) • BTK C481S • PLCG2 mutation • BTK C481 • BTK C481R • BTK C481Y
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Yinuokai (orelabrutinib) • Jaypirca (pirtobrutinib)
    1year
    Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study) (ASH 2023)
    Background: A phase II trial has shown, first-line treatment with iFCG (ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab) led to a bone marrow (BM) undetectable minimal residual disease (uMRD) rate of 98% (44/45) as best response in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). This is the first clinical trial exploring the efficacy and safety of the second generation BTKi plus chemoimmunotherapy in patients with CLL. The OFCG regimen shows a rapid and deep molecular remission with a pleasant safety profile in the TN CLL patients including the ones with unfavorable factors.
    Clinical • IO biomarker
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation • Chr del(11q) • TP53 mutation + Chr del(17p) • IGH mutation • Chr del(17p) + Chr del(11q)
    |
    Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • cyclophosphamide • Yinuokai (orelabrutinib) • fludarabine IV
    1year
    A Prospective Multicenter Phase II Study of Orelabrutinib-Lenalidomide-Rituximab (OLR) in Patients with Untreated Mantle Cell Lymphoma (MCL) in China (POLARIS Study): Preliminary Analysis on Efficacy, Safety, Mutation Spectrum and Impact of Mutation Profiling on Treatment Responses (ASH 2023)
    The preliminary findings show that the OLR exerted synergistic antitumor activity, with manageable toxicity in untreated MCL. Detection of PB ctDNA by NGS method may help to predict prognosis.
    Clinical • P2 data
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • DNMT3A (DNA methyltransferase 1) • NOTCH1 (Notch 1) • TERT (Telomerase Reverse Transcriptase) • CCND1 (Cyclin D1) • KMT2D (Lysine Methyltransferase 2D) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CDK12 (Cyclin dependent kinase 12) • BCOR (BCL6 Corepressor) • BIRC3 (Baculoviral IAP repeat containing 3) • FAT1 (FAT atypical cadherin 1) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • CARD11 (Caspase Recruitment Domain Family Member 11) • ARID2 (AT-Rich Interaction Domain 2) • GRIN2A (Glutamate Ionotropic Receptor NMDA Type Subunit 2A) • KDM5A (Lysine Demethylase 5A) • KLHL6 (Kelch Like Family Member 6) • MAP3K14 (Mitogen-Activated Protein Kinase Kinase Kinase 14) • NFKBIE (NFKB Inhibitor Epsilon) • FANCC (FA Complementation Group C)
    |
    TP53 mutation • ATM mutation
    |
    Rituxan (rituximab) • lenalidomide • Yinuokai (orelabrutinib)
    1year
    Efficacy and Safety of BTK Inhibitors in Vitreoretinal Lymphoma: A Single-Center, Retrospective Analysis of 24 Patients (ASH 2023)
    All 24 patients were treated with a BTK inhibitor (Zanubrutinib 160mg bid, or Orelabrutinib 150mg qd), of whom, 9 VRL patients were also treated with intravitreal methotrexate injection (0.4mg/ time, weekly ×12 times → monthly ×9 times) concurrently, and the remaining 15 patients did not receive any antitumor therapy other than BTK inhibitors... This is the largest report regarding the use of BTK inhibitors in VRL patients. BTK inhibitor has a rapid local control effect on VRL and is well tolerated. However, BTK inhibitors monotherapy has unsatisfied preventive effect on the CNS, and it is still necessary to explore the value of combinational therapy, such as combined BTK inhibitors and high-dose methotrexate.
    Retrospective data
    |
    IL10 (Interleukin 10) • IL6R (Interleukin 6 receptor)
    |
    IL10 elevation
    |
    Brukinsa (zanubrutinib) • Yinuokai (orelabrutinib) • methotrexate IV
    1year
    Combination of Selinexor with BTK Inhibitor for Central Nervous System Diffuse Large B-Cell Lymphoma, Possible Mechanisms and Therapeutic Potential Exploration (ASH 2023)
    Combining Selinexor(1μM) with ICP-022(2μM), a BTKi, resulted in more notable inhibition of the above tumor signaling pathways...2 others were on maintenance therapy with Selinexor combined with Zanubrutinib, one of them has completed the two-year maintenance treatment and maintained sustained remission till now... This is the first report describing that Selinexor combined with BTKi can synergistically inhibit the DLBCL tumor signaling pathway and repairing the immune microenvironment. Correspondingly, in treatment of central DLBCL patients, the novel therapeutic strategy of MSZ regimen has achieved impressive results, with a CRR of 100%. Most patients attained early and rapid deep remissions with durable efficacy.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule) • XPO1 (Exportin 1) • FOXO3 (Forkhead box O3) • NFATC1 (Nuclear Factor Of Activated T Cells 1)
    |
    PD-1 expression • HAVCR2 expression
    |
    Brukinsa (zanubrutinib) • Xpovio (selinexor) • Yinuokai (orelabrutinib) • methotrexate IV
    1year
    Clinicopathologic and mutational profiles of primary breast diffuse large B cell lymphoma in a male patient: case report and literature review. (PubMed, World J Surg Oncol)
    We reported a relatively rare PB-DLBCL in a male, non-GBC phenotype, dual-expression type. It is worth mentioning that this case had IgH/BCL6 fusion, nonsense mutations in TNFAIP3, frameshift mutations in PRDM1, and missense mutations in CREBBP, DTX1, and FOXO1. To the best of our knowledge, this case is the first report of genomic mutational profiles of PB-DLBCL in males.
    Review • Journal • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6) • CREBBP (CREB binding protein) • TNFAIP3 (TNF Alpha Induced Protein 3) • IRF4 (Interferon regulatory factor 4) • MME (Membrane Metalloendopeptidase) • PRDM1 (PR/SET Domain 1)
    |
    CD20 positive • BCL2 positive • CREBBP mutation • MYC rearrangement • BCL6 rearrangement • BCL2 rearrangement • PRDM1 mutation • BCL6 positive • BCL6 fusion
    |
    Rituxan (rituximab) • cytarabine • Yinuokai (orelabrutinib)
    1year
    ORMD2021: A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Huashan Hospital | Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    Rituxan (rituximab) • Yinuokai (orelabrutinib)
    1year
    A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking University People's Hospital | Trial completion date: Jun 2023 --> Aug 2024 | Trial primary completion date: Feb 2023 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Yinuokai (orelabrutinib)
    1year
    Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors (clinicaltrials.gov)
    P=N/A, N=30, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment open • Trial completion date • Trial primary completion date
    |
    CCND1 (Cyclin D1)
    |
    CCND1 expression
    |
    Yinuokai (orelabrutinib)
    1year
    BELIEVE-01: A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P3, N=150, Recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Trial primary completion date: Jun 2023 --> Jul 2024
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Yinuokai (orelabrutinib)