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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:
    2d
    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)
    3d
    A041702: Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3, N=465, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Dec 2026
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
    4d
    BP41072: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1/2, N=498, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm) • englumafusp alfa (RG6076)
    4d
    GP-1: Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma (clinicaltrials.gov)
    P1/2, N=53, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P1/2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Gazyva (obinutuzumab) • pomalidomide
    5d
    Fixed-duration VenO vs FCR/BR in fit patients with untreated CLL: primary analysis of the phase 3 CRISTALLO trial. (PubMed, Blood)
    The phase 3 CRISTALLO trial (NCT04285567) compared first-line fixed-duration venetoclax-obinutuzumab (VenO) vs fludarabine, cyclophosphamide, and rituximab (FCR)/bendamustine-rituximab (BR) in patients with chronic lymphocytic leukemia, using undetectable minimal residual disease (uMRD) as the sole primary endpoint. No patient in the VenO arm was deemed high-risk for tumor lysis syndrome following obinutuzumab debulking; no clinical TLS occurred. These results confirm and extend the findings from the GAIA-CLL13 trial, validating increased depth of response with VenO vs chemoimmunotherapies.
    P3 data • Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • cyclophosphamide • bendamustine • fludarabine IV
    8d
    MOONSHOT: CLL11 - A study to evaluate the efficacy of Epcoritamab consolidation in high genomic risk and Measurable Residual Disease (MRD)-positive Chronic Lymphocytic Leukaemia (CLL) patients after first-line venetoclax and obinutuzumab (ACTRN12625000387426)
    P2, N=38, Recruiting, Australasian Leukaemia and Lymphoma Group (ALLG) | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date • Minimal residual disease
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation • Chr del(11q)
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Epkinly (epcoritamab-bysp)
    9d
    BruVenG: Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting
    Enrollment closed • Minimal residual disease
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib)
    9d
    Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a fully academic, single-arm, open, prospective, intervention trial (2025-523306-33-00)
    P1/2, N=10, Not yet recruiting, Istituto Di Ricerche Farmacologiche Mario Negri
    New P1/2 trial
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab)
    11d
    MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma. (PubMed, Blood Adv)
    This safe and active regimen is feasible as a time-limited initial therapy for patients with MCL and warrants further evaluation in response-adapted strategy. This trial was registered at www.ClinicalTrials.gov as NCT03863184.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    clonoSEQ
    |
    Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    15d
    NCI-2023-03181: Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma (clinicaltrials.gov)
    P1/2, N=50, Recruiting, City of Hope Medical 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) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • KMT2D (Lysine Methyltransferase 2D) • NOTCH2 (Notch 2) • SOX11 (SRY-Box Transcription Factor 11) • NSD2 (Nuclear Receptor Binding SET Domain Protein 2)
    |
    TP53 mutation • Chr t(11;14)
    |
    Venclexta (venetoclax) • lenalidomide • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    16d
    Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P2, N=52, Recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Oct 2026 | Trial primary completion date: Dec 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    16d
    CLL16: A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) (2023-506414-46-00)
    P2/3, N=232, Recruiting, University Of Cologne
    New P2/3 trial
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)