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    DRUG:

    Gazyva (obinutuzumab)

    i
    Other names: GA101, R 7159, RO 5072759, GA 101, R7159, RG 7159, RG7159, RO5072759, GA-101, R-7159, RG-7159, RO-5072759
    Company:
    Biogen, Nippon Shinyaku, Roche
    Drug class:
    CD20 inhibitor
    Related drugs:
    22h
    Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=24, Suspended, University of Utah | Recruiting --> Suspended
    Trial suspension
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Tazverik (tazemetostat)
    7d
    Venetoclax combinations in untreated CLL: 5-year results and patient-reported outcome analysis of the CLL13/GAIA trial. (PubMed, Blood)
    The phase 3 CLL13/GAIA trial assesses three time-limited combinations: venetoclax-rituximab (RV), venetoclax-obinutuzumab (GV), and venetoclax-obinutuzumab-ibrutinib (GIV) compared to chemoimmunotherapy (CIT). Fit patients with CLL without TP53 aberrations were randomized between six cycles of CIT (fludarabine-cyclophosphamide-rituximab [FCR], bendamustine-rituximab [BR]) or 12 cycles of RV, GV or GIV (GIV: ibrutinib continuation until cycle 36 if measurable residual disease [MRD] at months 12/15)...In the GIV arm, clinically relevant QoL improvements occurred later (month 15, after the end of treatment in most patients) than with GV/RV, likely due to a higher treatment-related symptom burden. The trial is registered at clinicltrial.gov with the identifier, NCT02950051.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • cyclophosphamide • bendamustine • fludarabine IV
    7d
    TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Brown University
    New P2 trial
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD4 (CD4 Molecule) • IRF4 (Interferon regulatory factor 4)
    |
    Gazyva (obinutuzumab) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
    9d
    STEP-WISE COMBINATION OF OBINUTUZUMAB, VEMURAFENIB AND COBIMETINIB IN PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) PREVIOUSLY TREATED WITH PURINE ANALOGS OR UNFIT FOR CHEMOTHERAPY: A PHASE-2, SINGLE-ARMS, ITALIAN, MULTICENTER STUDY (HCL-PG04) (2024-520121-36-00)
    P1/2, N=50, Recruiting, Universita' Degli Studi Di Perugia | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene) • IL2RA (Interleukin 2 receptor, alpha) • ANXA1 (Annexin A1) • ITGAE (Integrin Subunit Alpha E) • ITGAX (Integrin Subunit Alpha X) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
    |
    BRAF V600E • BRAF V600
    |
    Zelboraf (vemurafenib) • Cotellic (cobimetinib) • Gazyva (obinutuzumab)
    10d
    BGB-11417-101: Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies (clinicaltrials.gov)
    P1, N=437, Active, not recruiting, BeOne Medicines | Trial completion date: Aug 2027 --> May 2027 | Trial primary completion date: Aug 2027 --> May 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • sonrotoclax (BGB-11417)
    11d
    Ocular toxicity associated with anti-CD20 monoclonal antibodies: A pharmacovigilance analysis using the FAERS database. (PubMed, Mult Scler Relat Disord)
    Anti-CD20 antibodies require careful ocular monitoring, particularly in multiple sclerosis patients. The elevated blepharospasm risks with ofatumumab and dyschromatopsia with rituximab highlights potential CNS-and optic pathway-related effects that warrant further study to improve MS treatment safety.
    Journal • Adverse events
    |
    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab)
    11d
    Successful Treatment of Persistent and Relapsing COVID-19 with Ensitrelvir in a Patient with Obinutuzumab-Induced Long-Term B-Cell Depletion: A Case Report. (PubMed, Reports (MDPI))
    Compared with remdesivir and molnupiravir, ensitrelvir achieves higher rates of SARS-CoV-2 antigen clearance and a more favorable viral shedding profile. Case Presentation: A 67-year-old Japanese man with follicular lymphoma had received obinutuzumab plus bendamustine, followed by obinutuzumab maintenance therapy...Three months prior to the current admission, the patient developed coronavirus disease 2019 (COVID-19) and was treated with a 10-day course of remdesivir and dexamethasone... Ensitrelvir may be an effective therapeutic option for the treatment of persistent or refractory COVID-19 in immunocompromised patients. Clinicians should recognize that patients treated with obinutuzumab may remain immunosuppressed for several years after therapy.
    Journal
    |
    CRP (C-reactive protein)
    |
    Gazyva (obinutuzumab) • dexamethasone • bendamustine
    11d
    A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    lenalidomide • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    14d
    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)
    16d
    Rituximab and obinutuzumab in SLE (2024-518965-85-00)
    P4, N=20, Recruiting, Amsterdam UMC Stichting | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab)
    19d
    BGB-11417-303: A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) (clinicaltrials.gov)
    P3, N=630, Recruiting, BeOne Medicines
    Trial initiation date
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • sonrotoclax (BGB-11417)
    19d
    Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (clinicaltrials.gov)
    P2, N=230, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)