Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   162 Trials   162 Trials   4758 News 


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  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    The Case for Extending Treatment in MRD+ Patients on Venetoclax + Obinutuzumab Therapy () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_952;    
    When utilizing an MRD monitoring strategy for informed clinical decision making for patients with this regimen, we believe that the presently available data suggests a favorable benefit/risk profile for venetoclax continuation for MRD+ patients, with particularly strong rationale for therapy continuation in the highest-risk patient populations (TP53 aberrancy). We remain hopeful that as further randomized data becomes available, the best course of action for the management of MRD+ patients will be better defined.
  • ||||||||||  Is Fixed-Duration Therapy the New Standard of Care in Frontline CLL? () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_951;    
    An improved understanding of the disease biology has contributed to the development of novel agents able to target key pathways in CLL.2 Two classes of targeted agents have been extremely impactful in shaping current treatment of CLL: the BCL2 inhibitor venetoclax and the Bruton's tyrosine kinase inhibitors (BTKi) ibrutinib, acalabrutinib and zanubrutinib...Patients received six 28-day cycles of ibrutinib in combination with fludarabine, cyclophosphamide and rituximab (FCR) followed by 2 years of ibrutinib maintenance...The combination of ibrutinib-venetoclax demonstrated superior progression-free survival (24 months estimated rate 84.4% for patients treated with ibrutinib-venetoclax and 44.1% for patients treated with chlorambucil-obinutuzumab) and superior rates of U-MRD (55.7% vs 21%).15 The time-limited approach with concomitant administration of BTK and BCL2 targeting agents has potential advantages over continuous BTK inhibitor-based therapy in terms of reduced risk for treatment-related side effects due to the prolonged administration and potentially lower costs8 , however, there are still open questions in terms of selection of therapy at time of retreatment and quality and durability of responses to subsequent therapies. It is important to note that treatment with combination of BTKi and venetoclax with or without CD20 monoclonal antibodies is not FDA approved and is still being investigated in clinical trials.
  • ||||||||||  Covalent Inhibitors of BTK in the Treatment of CLL () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_940;    
    In the frontline setting, the ELEVATE-TN study compared acalabrutinib, either alone or in combination with obinutuzumab, to chlorambucil plus obinutuzumab...Frontline phase 3 trial data comes from the SEQUOIA study, where zanubrutinib was compared with bendamustine plus rituximab...The combination of ibrutinib plus venetoclax has received frontline approval from the EMA. Ongoing studies may offer future options of time-limited therapy involving covalent BTK, but current approaches with indefinite covalent BTK treatment offer a safe and effective strategy to treat CLL patients at this time.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Zydelig (idelalisib) / Gilead
    Trial completion, Trial completion date:  RemodelWM3: Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia (clinicaltrials.gov) -  Aug 29, 2023   
    P2,  N=50, Completed, 
    Prospective studies are needed to confirm the effectiveness of plitidepsin as a treatment for SARS-CoV-2 infection in patients with NHL who have received immunochemotherapy. Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Apr 2023
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen
    Trial primary completion date:  OLYMP-1: Obinutuzumab in Marginal Zone Lymphoma (clinicaltrials.gov) -  Aug 24, 2023   
    P2,  N=56, Active, not recruiting, 
    This study expands the information available on patients with CLL in Spain, describing the diversity in patient characteristics and therapeutic approaches in clinical practice. Trial primary completion date: Jun 2023 --> Jun 2024
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Trial completion date, Trial primary completion date:  The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) -  Aug 23, 2023   
    P2,  N=100, Recruiting, 
    Trial primary completion date: Jun 2023 --> Jun 2024 Trial completion date: Jul 2023 --> Jul 2026 | Trial primary completion date: Jul 2023 --> Jul 2026
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
    Trial completion date, Combination therapy:  A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) -  Aug 23, 2023   
    P1,  N=54, Active, not recruiting, 
    Trial completion date: Jul 2023 --> Jul 2026 | Trial primary completion date: Jul 2023 --> Jul 2026 Trial completion date: Jul 2023 --> Jan 2029
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
    Trial completion date, Trial primary completion date, Combination therapy, Minimal residual disease:  A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL (clinicaltrials.gov) -  Aug 18, 2023   
    P2,  N=55, Active, not recruiting, 
    Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Clinical outcomes in patients with chronic lymphocytic leukemia (CLL) treated with venetoclax-based regimens (Hynes Convention Center Meeting Room 302/304. Level 3 900 Boylston St., Boston, MA) -  Aug 14, 2023 - Abstract #IWCLL2023IWCLL_301;    
    Patients with BTKi-exposed CLL, particularly those with prior disease progression on BTKi, had worse outcomes. Our study identified CK as one of the most important baseline predictors of adverse TFS and OS in the overall cohort of patients, supporting karyotype assessment for prognostication prior to venetoclax treatment.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Venetoclax-Obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study () -  Aug 14, 2023 - Abstract #IWCLL2023IWCLL_222;    
    Five years after cessation of Ven-Obi, over half of the patients of this elderly patient population remained in remission, 8% still had uMRD and over 60% had not required second-line treatment. The 1-year Ven-Obi regimen is an effective fixed-duration option for patients with CLL and coexisting conditions.
  • ||||||||||  Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
    A matching-adjusted indirect comparison of ELEVATE-TN versus SEQUOIA: acalabrutinib with and without obinutuzumab versus zanubrutinib in treatment-na () -  Aug 14, 2023 - Abstract #IWCLL2023IWCLL_188;    
    Our results show that ibrutinib exerts a wide range of immune-modulating effects, which are mainly associated with the achievement of a clinical response to therapy. In this MAIC of ELEVATE-TN and SEQUOIA, acalabrutinib + obinutuzumab had a superior efficacy in terms of INV-PFS versus zanubrutinib, while acalabrutinib monotherapy and zanubrutinib had similar efficacies in patients with treatment-na
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Venetoclax Consolidation after BTKi Based Therapy for Patients with CLL () -  Aug 14, 2023 - Abstract #IWCLL2023IWCLL_173;    
    There has been increasing focus on investigating the combination BTKi and ven. However, combination therapy does increase the risk of hematologic and gastrointestinal side effects, which can lead to dose reduction or drug discontinuation [3].
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Real-World Duration of Venetoclax Treatment for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma () -  Aug 14, 2023 - Abstract #IWCLL2023IWCLL_166;    
    For patients treated for less than the fixed-dosing schedules, the mean DoT was <5 months in those treated with V + O and <7 months in those treated with V + R. Patients treated beyond the fixed-dosing schedules continued treatment for approximately 3 more months with V + O and 6 more months with V + R. This study provides evidence that a V-based approach may not be suitable for all patients with CLL/SLL. Future studies should include additional follow-up with a larger sample, reasons for treatment discontinuation, and patient molecular genetic profile.