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Clinical, Review, Journal: Risk-Adapted, Individualized Treatment Strategies of Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). (Pubmed Central) - Apr 7, 2021 Although early results from novel molecularly driven agents such as IDH1/2 inhibitors, venetoclax, magrolimab, and APR-246 for MDS as well as tagraxofusp, tipifarnib, and lenzilumab for CMML appear encouraging, confirmatory randomized trials must be completed to fully assess their safety and efficacy prior to routine clinical use. Herein, we review the current management of MDS and CMML and conclude with a critical appraisal of novel therapies and general trends in this field.
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[VIRTUAL] COVID-19 Pneumonia in Sickle Cell Anemia: A Case Report () - Mar 14, 2021 - Abstract #ATS2021ATS_945; She received intravenous remdesivir, dexamethasone, ceftriaxone, and azithromycin...She was consented and enrolled in a lenzilumab trial...This patient had sickle cell pain, and COVID-19 screening should be considered among those presenting with painful crises during this pandemic to avoid overlooking a possible inciting factor. Exchange transfusion was utilized in this case; further case studies and clinical trials would aid clinicians in understanding appropriate management when these illnesses co-exist.
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Clinical, Journal: Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019. (Pubmed Central) - Mar 13, 2021 Exchange transfusion was utilized in this case; further case studies and clinical trials would aid clinicians in understanding appropriate management when these illnesses co-exist. No abstract available
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Enrollment change, Trial completion date, Trial primary completion date: Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19 (clinicaltrials.gov) - Jan 22, 2021 P3, N=516, Recruiting, N/A Clinical Trial Registry: NCT04314843; website: https://clinicaltrials.gov/ct2/show/NCT04314843 N=300 --> 516 | Trial completion date: Sep 2020 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Mar 2021
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Trial completion date, Trial primary completion date: ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 (clinicaltrials.gov) - Jan 22, 2021 P2, N=200, Recruiting, N=300 --> 516 | Trial completion date: Sep 2020 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Mar 2021 Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jan 2021 --> Dec 2021
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Clinical, Journal: GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study. (Pubmed Central) - Dec 15, 2020 P3 In high-risk COVID-19 patients with severe pneumonia, granulocyte-macrophage colony-stimulating factor neutralization with lenzilumab was safe and associated with faster improvement in clinical outcomes, including oxygenation, and greater reductions in inflammatory markers compared with a matched control cohort of patients hospitalized with severe COVID-19 pneumonia. A randomized, placebo-controlled clinical trial to validate these findings is ongoing (NCT04351152).
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