Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   163 Trials   163 Trials   4765 News 


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  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Trial primary completion date:  CLL2-GiVe: Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL (clinicaltrials.gov) -  Oct 5, 2021   
    P2,  N=40, Active, not recruiting, 
    Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2021 --> Feb 2023 Trial primary completion date: Dec 2020 --> Jan 2022
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Clinical, Journal:  Skipping a step or "impatientitis": what happened to the design of randomized clinical trials in chronic lymphocytic leukaemia? (Pubmed Central) -  Sep 30, 2021   
    Similarly, two large trials omitted venetoclax monotherapy and proceeded directly to venetoclax + rituximab or obinutuzumab versus chemoimmunotherapy...Thus, we are left with regimens which are undoubtedly effective, but might actually be unnecessarily toxic and expensive. The solution to this problem is simple: future randomized trials should be carefully designed in a 'step by step' fashion which would provide the CLL community with simple yet robust answers regarding efficacy of novel regimens so that these can be introduced to practice following the best principles of evidence-based medicine.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  From pathogenesis to personalized treatments of neuropathies in hematological malignancies. (Pubmed Central) -  Sep 29, 2021   
    Recently, high-throughput technologies, and next-generation sequencing have increased our knowledge of hematological diseases pathogenesis by the identification of somatic mutation affecting pivotal signalling pathways. Accordingly, new target therapies are used that may also be borrowed for treatment of neuropathies in hematological diseases.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Enrollment change, Trial suspension:  VENOBI-CNS: Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma (clinicaltrials.gov) -  Sep 22, 2021   
    P1,  N=4, Suspended, 
    No abstract available N=15 --> 4 | Recruiting --> Suspended
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
    New P2 trial:  ORION: Obinutuzumab in Primary MN (clinicaltrials.gov) -  Sep 19, 2021   
    P2,  N=20, Not yet recruiting, 
  • ||||||||||  Arzerra (ofatumumab) / Novartis, Genmab
    Journal:  Monoclonal Antibodies, Bispecific Antibodies and Antibody-Drug Conjugate in Oncohematology. (Pubmed Central) -  Sep 19, 2021   
    Trial completion date: Aug 2021 --> Nov 2024 | Trial primary completion date: Aug 2021 --> Nov 2024 Immunotherapy and immuno-chemotherapy have improved the outcome of the patients with malignant hemopathies through a targeted, personalized therapy, with reduced systemic toxicity, which in some cases can even induce deep complete remissions, including minimal residual disease negativity.
  • ||||||||||  rhIL-15 / National Cancer Institute
    Enrollment change, Trial suspension:  Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia (clinicaltrials.gov) -  Sep 16, 2021   
    P1,  N=1, Suspended, 
    Immunotherapy and immuno-chemotherapy have improved the outcome of the patients with malignant hemopathies through a targeted, personalized therapy, with reduced systemic toxicity, which in some cases can even induce deep complete remissions, including minimal residual disease negativity. N=24 --> 1 | Recruiting --> Suspended
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  The current therapeutic landscape for follicular lymphoma (Pubmed Central) -  Sep 10, 2021   
    For advanced-stage low tumor burden patients, watchful waiting remains the standard treatment, whereas rituximab monotherapy may be an alternative option...Recently, the novel anti-CD20 monoclonal antibody obinutuzumab was approved for the treatment of FL...During the last decade, the development of biological knowledge and use of molecularly targeted agents offer new therapeutic perspectives with chemo-free strategies. This review highlights the current standards for the treatment of FL.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Enrollment open, Trial initiation date, Monotherapy:  SAVE: Safe Accelerated Venetoclax Escalation in CLL (clinicaltrials.gov) -  Sep 9, 2021   
    P1,  N=40, Recruiting, 
    This review highlights the current standards for the treatment of FL. Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Apr 2021
  • ||||||||||  Revlimid (lenalidomide) / BMS
    Looking past a Positive Clostridioides difficile Test (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_767;    
    Stool PCR for C. difficile had been positive two months prior and diarrhea persisted despite multiple courses of vancomycin and fidaxomicin...She was discharged home on valganciclovir and seen in clinic six weeks later with complete resolution of her diarrhea...Other causes of colitis should be considered when symptoms persist despite anti-CDI therapies, especially in immunocompromised patients. We present two cases of CMV colitis masquerading as CDI.Figure: Colonic ulceration secondary to CMV colitis
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
    Chronic Lymphoid Leukemia With Extensive Liver Infiltration in the Absence of Leukemic Transformation (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_244;    
    Patient reported taking glimepiride, atorvastatin and herbal supplements (GNC50+ multivitamin, fertility and prostate multivitamin) that were stopped five months prior to encounter due to concerns of drug-induced liver injury (DILI)...Patient was initiated on Venetoclax and Obinutuzumab as an outpatient...Due to severe pattern of liver infiltration, worsening LE, portal hypertension, and hepatosplenomegaly it was ultimately decided to start patient on chemotherapy.Figure: Image A:CT abdomen and pelvis with IV contrast depicting an enlarged 33.4x42.9mm periportal lymph nodeImage B: CT abdomen and pelvis with IV contrast depicting 11.7x18.3mm pancreatic lymph nodeImage C: : H&E; (400x) section demonstrates an atypical lymphoid follicle surrounding bile ductules, with adjacent liver parenchyma. Characteristic immunohistochemical staining of the neoplastic cells shows positivity for CD20 (dim), CD5, CD23, and is negative for CD3Image D: ZAP 70 (400x) staining (brown) of neoplastic cells has been associated with a poor prognosis
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
    Journal:  An update of venetoclax and obinutuzumab in chronic lymphocytic leukemia. (Pubmed Central) -  Sep 8, 2021   
    Venetoclax, an oral anti-apoptotic BCL-2 inhibitor, in combination with a CD20 antibody has shown superiority to chemoimmunotherapy in treatment-naive and relapsed/refractory CLL. Obinutuzumab is a novel anti-CD20 monoclonal antibody that has been safely combined with novel agents including venetoclax and Bruton tyrosine kinase inhibitors and has shown superiority over rituximab when combined with chlorambucil.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Calquence (acalabrutinib) / AstraZeneca
    [VIRTUAL] Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naïve Chronic Lymphocytic Leukemia: ELEVATE-TN 4-Year Followup () -  Sep 6, 2021 - Abstract #SOHO2021SOHO_513;    
    P3
    Obinutuzumab is a novel anti-CD20 monoclonal antibody that has been safely combined with novel agents including venetoclax and Bruton tyrosine kinase inhibitors and has shown superiority over rituximab when combined with chlorambucil. With a median follow-up of 46.9 months (~4y), the efficacy and safety of A+O and A monotherapy was maintained, with an increase in CR since the interim analysis (from 21% to 27% [A+O] and from 7% to 11% [A]) and low rates of discontinuation.