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<label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-md" itemscope itemtype="https://schema.org/WebPage"><div id="condition-header"><h1 class="mb-2" itemprop="headline"> <strong>Monoclonal Antibody</strong> clinical trials at UCSF </h1><p class="h3 mb-5 text-muted" id="condition-header--clinical-trial-counts"> 1 research study open to eligible people </p><div class="row"><p id="condition-header--clinical-trial-portfolio-description" class="trials-list-header--explanatory-paragraph col col-md-9 col-lg-8" itemprop="description speakable"> Monoclonal antibodies are lab-engineered proteins that can bind to specific targets in the body. UCSF is researching whether Montelukast can reduce the frequency and severity of reactions during cancer treatments involving monoclonal antibodies. This trial aims to enhance the safety of these treatments. </p></div></div><div class="row"> <div class="col col-md-9 col-lg-8 "> <div class="trials-list--filter-container card bg-light text-center mb-3 d-none d-print-none" data-nosnippet><div class="card-body p-1"><span class="trials-list--filter-main-heading d-none d-md-inline"> Showing <span class="trials-list--number-of-trials-shown" aria-live="assertive"></span> trials for </span><div class="btn-group btn-group-sm btn-group-toggle ml-3" role="group" aria-label="Filter trials by sex/gender" data-toggle="buttons"> <label class="btn btn-light mr-1 active"> <input checked type="radio" name="trials-list--filter-sex" data-class-wanted=""> <i class="fa fa-male d-none d-lg-inline" aria-hidden="true"></i><i class="fa fa-female d-none d-lg-inline" aria-hidden="true"></i> All </label> <label class="btn btn-light mr-1"> <input type="radio" name="trials-list--filter-sex" data-class-wanted="trials-list--trial-open-to-sex-female"> <i class="fa fa-female d-none d-lg-inline" aria-hidden="true"></i> Female </label> <label class="btn btn-light mr-1"> <input type="radio" name="trials-list--filter-sex" data-class-wanted="trials-list--trial-open-to-sex-male"> <i class="fa fa-male d-none d-lg-inline" aria-hidden="true"></i> Male </label> </div><div class="btn-group btn-group-sm btn-group-toggle ml-3" role="group" aria-label="Filter trials by age range" data-toggle="buttons"> <label class="btn btn-light active"><input checked type="radio" name="trials-list--filter-age" data-class-wanted="">All ages</label> <label class="btn btn-light"><input type="radio" name="trials-list--filter-age" data-class-wanted="trials-list--trial-open-to-age-under-18">Under 18</label> <label class="btn btn-light"><input type="radio" name="trials-list--filter-age" data-class-wanted="trials-list--trial-open-to-age-18-and-over">Over 18</label> </div></div></div> <ul class="list-unstyled" id="trials-list"><li class="trials-list--trial card border trials-list--trial-joinable trials-list--trial-open-to-age-18-and-over trials-list--trial-open-to-sex-female trials-list--trial-open-to-sex-male "><div class="card-body"><h2 class="h4 card-title"> <a href="https://clinicaltrials.ucsf.edu/trial/NCT04198623" class="stretched-link">Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions</a> </h2><div class="trials-list--trial-details"><p class="h6 "> <i class="fa fa-user d-none d-md-inline" aria-hidden="true"></i> open to eligible people ages 18 years and up </p><div class="trials-list--trial-summary"><p>The use of monoclonal antibodies (MA) either alone or as part of chemoimmunotherapy in oncology, benign and malignant hematology is expanding. Of the 17 therapeutic MAs approved in 2017 by FDA, 50% of them are indicated for hematologic and oncologic condition. With increasing number of approved agents, therapeutic MAs have become one of the fastest growing areas in the management of benign and malignant hematologic condition. Advancement of recombinant technology allows development of partially or fully humanized new agents. Despite this, they still carry significant risk of immune and non-immune mediated adverse events. Most of the therapeutic monoclonal antibody related adverse events (MCAAE) The severity of reaction is variable, ranging from mild involvement of single organ to severe and life-threatening reactions requiring hospitalization or even resulting in death. Even for mild infusion reactions, where re-initiation of infusion is possible, there is resultant delay in delivery of infusions, distress to patients, and additional utilization of health care resources. Due to unpredictability of standard infusion reaction (SIR), efforts have been focused on premedication to decreasing the incidence and severity of infusion reaction. Most institutions have protocols using corticosteroid, acetaminophen and antihistamine as part of their premedication protocols. This has reduced but not eliminated standard infusion reactions. Most recently, mast cell stabilizers are being added to standard protocols to further reduce the incidence and severity of standard infusion reactions with variable anecdotal success without formal study. Of all the monoclonal antibodies, only Daratumumab has been evaluated using this strategy. This study seeks to evaluate the efficacy of mast cell stabilizer Montelukast (SINGULAIR) 10 mg in decreasing the SIR in patients receiving therapeutic MAs either alone or as part of chemoimmunotherapy in hematologic condition. The MAs being studied includes: Blinatumomab (BLINCYTO, Amgen Inc.), Daratumumab (DARZALEX, Janssen Biotech, Inc.), Elotuzumab (EMPLICIT, Bristol-Myers Squibb Company), Gemtuzumab (MYLOTARG, Pfizer Inc.), Obinutuzumab (GAZYVA, Genentech USA, Inc.), and Rituximab (RITUXAN, Genentech US); The investigators postulate that 10 mg of Montelukast, when given in addition to standard premedication, will lead to decrease in incidence of MA associated SIR, shorter infusion time and decrease use of additional health care resources</p></div><p itemprop="location" itemscope itemtype="https://schema.org/Place" class="text-right text-muted small"><meta itemprop="name" content="Community Cancer Institute"> <i class="fa fa-map-marker fa-fw" aria-hidden="true"></i> <span itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"> <strong> <span itemprop="addressLocality">Clovis</span>, <span itemprop="addressRegion">California</span><meta itemprop="postalCode" content="93611"><meta itemprop="addressCountry" content="United States"> </strong> </span></p></div></div></li></ul><div><p class="text-muted small comma-list"> Our lead scientists for Monoclonal Antibody research studies include <span class="pi-name comma-list-item" itemprop="author" itemscope itemtype="https://schema.org/Person"><a href="https://profiles.ucsf.edu/mohammed.bukari" target="_blank" rel="noopener author" itemprop="url" class="condition--link-to-pi-profile"><span itemprop="name">MOHAMMED BUKARI, MD</span></a></span>. </p><p class="text-muted small">Last updated: <time itemprop="dateModified" datetime="2023-11-15">November 2023</time></p></div></div> <div class="col-md-3 col-lg-3 offset-lg-1"><aside class="d-print-none"><h3 class="h5 mt-5" role="complementary">Related Links</h3><ul><li><a href="https://www.ucsfhealth.org/find-a-doctor/" rel="nofollow">UCSF Health doctors</a></li><li><a href="https://www.researchmatch.org/" rel="nofollow">More studies at ResearchMatch</a></li><li><a href="https://www.ucsf.edu/search?search=Monoclonal%20Antibody" rel="nofollow">Monoclonal Antibody resources at UCSF</a></li></ul></aside></div> </div> </div> </main><footer class="mt-auto" role="contentinfo" data-nosnippet><div id="ucsf--footer--body"><div class="container" data-nosnippet><div class="row mb-1 d-print-none"><div class="col-12 text-center text-md-left"> We use cookies to operate our website, analyze performance, and improve your experience on our site. <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Learn more.</a> </div></div><div class="row"><div class="col-md-6 text-center text-md-left"><p class="my-0"> © The Regents of the University of California </p></div><div class="col-md-6 text-center text-md-right pt-3 pt-md-0"> <a href="https://websites.ucsf.edu/digital-accessibility" target="_blank">Accessibility</a> <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Privacy Policy</a> <a href="https://websites.ucsf.edu/website-terms-use" target="_blank">Terms of Use</a> </div></div></div></div></footer><script>(function(){var b=document.createElement('script');b.type='text/javascript';b.async=true;b.src='//siteimproveanalytics.com/js/siteanalyze_8343.js';var a=document.getElementsByTagName('script')[0];a.parentNode.insertBefore(b,a)})();</script></body></html>