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class="form-inline my-1" role="search"> <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-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><h1 id="summary--title"> Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../acute-lymphoblastic-leukemia">Acute Lymphoblastic Leukemia</a></span><span class="comma-list-item"> <a href="../leukemia">Leukemia</a></span><span class="comma-list-item"> <a href="../lymphoma">Lymphoma</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 15-40</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at Oakland, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2023-08-24">August 2023</time></span></div><div> completion around <time datetime="2027-12-31">December 2027</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2022-11-02"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/jennifer.michlitsch" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Jennifer G. Michlitsch</a></span></span><span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/maria.castellanos" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Maria I. Castellanos</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=33508935" alt="Headshot of Jennifer G. Michlitsch" loading="lazy"><figcaption class="figure-caption">Jennifer G. Michlitsch</figcaption></figure><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=230490597" alt="Headshot of Maria I. Castellanos" loading="lazy"><figcaption class="figure-caption">Maria I. Castellanos</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of <a href="../acute-lymphoblastic-leukemia" class="trial--link-to-condition-in-text">acute lymphoblastic leukemia</a> (ALL), <a href="../lymphoma" class="trial--link-to-condition-in-text">lymphoblastic lymphoma</a> (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>PRIMARY OBJECTIVE:</p><ol type="a"><li>To determine in a randomized manner whether the addition of levocarnitine prophylaxis to asparaginase-containing regimens will decrease the incidence of conjugated hyperbilirubinemia (> 3 mg/dL) during ALL induction therapy for adolescents and young adults (adolescents and young adults [AYAs], age 15-39 years).</li></ol><p>SECONDARY OBJECTIVES:</p><ol type="a"><li>To examine the impact of levocarnitine prophylaxis on differences in the incidence of grade >= 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations during ALL Induction.</li></ol><p>II. To compare rates of minimal residual disease (MRD) positivity at end of Induction and describe MRD+ by end of consolidation (EOC) in those receiving ALL induction chemotherapy with and without levocarnitine.</p><p>EXPLORATORY OBJECTIVES:</p><ol type="a"><li>To compare rates of toxicity and associated dose reductions for chemotherapy administered with and without concomitant levocarnitine supplementation.</li></ol><p>II. To compare across study arms the peak levels during Induction of conjugated and total bilirubin, AST, ALT, and duration of conjugated hyperbilirubinemia from onset > 3 mg/dL to =< 3 mg/dL.</p><p>III. To describe the efficacy of levocarnitine prophylaxis to reduce the incidence and/or severity of early patient-reported chemotherapy-induced <a href="../peripheral-neuropathy" class="trial--link-to-condition-in-text">peripheral neuropathy</a>.</p><p>IV. To describe the three-year event-free and overall survival (EFS/OS) in those treated with and without levocarnitine prophylaxis.</p><ol type="a"><li>To examine the association of age with asparaginase activity and asparaginase-associated hepatotoxicity during induction.</li></ol><p>VI. To examine the association of body-mass-index (BMI) percentile (or absolute BMI for young adults) with asparaginase activity and asparaginase-associated hepatotoxicity during induction.</p><p>VII. To describe <a href="../treatment-adherence" class="trial--link-to-condition-in-text">adherence</a> by self-report and pill-count to oral levocarnitine in patients randomized to the intervention arm.</p><p>VIII. To examine the association of plasma levels of carnitine and related markers with the efficacy of levocarnitine supplementation.</p><p>IX. To determine the impact of inherited genetic variation on hepatoxicity and levocarnitine efficacy.</p><p>OUTLINE: Patients are randomized to 1 of 2 arms (arm A vs. B).</p><p>ARM A: Patients receive levocarnitine orally (PO) or intravenously (IV) prior to standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.</p><p>ARM B: Patients receive standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.</p><p>ARM C (RESCUE): Patients in Arms A and B who develop conjugated hyperbilirubinemia > 3 mg/dL during induction may receive levocarnitine rescue PO or IV supplementation until resolution of conjugated hyperbilirubinemia =< 3 mg/dL (or start of consolidation or the next treatment phase, whichever occurs first).</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../acute-lymphoblastic-leukemia" class="trial--link-to-condition-in-text">B Acute Lymphoblastic Leukemia</a></span>, <span> B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1</span>, <span> B Acute Lymphoblastic Leukemia, BCR-ABL1-Like</span>, <span> <a href="../lymphoma" class="trial--link-to-condition-in-text">Lymphoblastic Lymphoma</a></span>, <span> Mixed Phenotype Acute Leukemia</span>, <span> T Acute Lymphoblastic Leukemia</span>, <span> Lymphoma</span>, <span> Leukemia</span>, <span> Precursor Cell Lymphoblastic Leukemia-Lymphoma</span>, <span> Lymphoid Leukemia</span>, <span> Precursor T-Cell Lymphoblastic Leukemia-Lymphoma</span>, <span> Asparaginase</span>, <span> Pegaspargase</span>, <span> Biospecimen Collection</span>, <span> Calaspargase Pegol</span>, <span> Levocarnitine</span>, <span> Quality-of-Life Assessment</span>, <span> rescue levocarnitine</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 15-40</strong></p><ul><li>>= 15 and < 40 years at time of diagnosis</li><li>Newly diagnosed B-ALL, T-ALL, <a href="../lymphoma" class="trial--link-to-condition-in-text">lymphoblastic lymphoma</a> (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL) <ul><li> Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors [TKI] or CRLF2- targeted concomitant medication must be documented, if used)</li></ul></li><li>Conjugated bilirubin =< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and</li><li>Serum glutamate pyruvate transaminase (SGPT) (ALT) =< 225 U/L (=< 5x ULN) (within 7 days prior to enrollment), and <ul><li> Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline</li></ul></li><li>SGOT (AST) =< 250 U/L (=< 5x ULN) (within 7 days prior to enrollment) <ul><li> Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline</li></ul></li><li>Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of >= 1 dose of pegaspargase or calaspargase pegol, and</li><li>First dose of asparaginase must be planned within the first week of induction therapy, and</li><li><p>Dose of pegaspargase or calaspargase pegol must be >= 1,000 IU/ m<sup>2</sup> (dose-capping permitted per primary regimen)</p><ul><li> Note: Co-enrollment on a therapeutic consortia trial is not required</li></ul></li><li>All patients and/or their parents or legal guardians must sign a written informed consent</li><li>All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ul><li>Down syndrome</li><li>Known inherited or autoimmune <a href="../liver-disease" class="trial--link-to-condition-in-text">liver disease</a> impacting conjugated bilirubin (e.g., <a href="../alagille-syndrome" class="trial--link-to-condition-in-text">Alagille syndrome</a>, <a href="../primary-sclerosing-cholangitis" class="trial--link-to-condition-in-text">primary sclerosing cholangitis</a>, other)</li><li>Known biopsy (or imaging) proven severe <a href="../fibrosis" class="trial--link-to-condition-in-text">liver fibrosis</a> (Batts-Ludwig >= stage 3)</li><li>Patients who received chemotherapy or treatment for a prior malignancy are not eligible <ul><li> The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a>) is also permitted and must be documented</li></ul></li><li>Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential</li><li>Lactating females who plan to breastfeed their infants</li><li>Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Benioff Children's Hospital Oakland</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Oakland</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94609</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Medical Center-Mission Bay</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94158</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Valley Children's Hospital</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Madera</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 93636</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Stanford Cancer Institute Palo Alto</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Palo Alto</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94304</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientists <span class="d-none d-sm-inline">at UCSF</span></h2><ul class=""><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/jennifer.michlitsch" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Jennifer G. Michlitsch</a> </strong> </span><br> Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications </li><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/maria.castellanos" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Maria I. Castellanos</a> </strong> </span><br> My research goal is to characterize, study, and identify remedies to mitigate the socioeconomic, biological, and clinical factors that impact treatment outcomes and survival in children with cancer, with a specific interest in pediatric leukemias. I study geospatial differences among communities that impact cancer survival outcomes. </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2023-08-24">August 2023</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2027-12-31">December 2027</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Children's Oncology Group</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT05602194" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT05602194</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 3 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">Expecting 440 study participants</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-10-18">October 18, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div><div class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? 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Submitting your contact information does not obligate you to participate in research.</p></div> </div></div></div><div class="modal fade" id="contact-thank-you-modal" tabindex="-1" role="dialog" aria-hidden="true" aria-labelledby="contact-modal-label"><div class="modal-dialog" role="document"><div class="modal-content"><div class="modal-header"> <button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button> <h4 class="modal-title h5" id="contact-thank-you-modal-label">Thank you!</h4></div><div class="modal-body"><p>The study team should get back to you in a few business days.</p><p>You will also receive an email with next steps. Check your junk/spam folder if needed.</p><p>If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT05602194.</p></div><div class="modal-footer"> <button type="button" class="btn btn-primary" data-dismiss="modal">OK</button> </div></div></div></div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy","code":{"@type":"MedicalCode","codeValue":"NCT05602194","codingSystem":"ClinicalTrials.gov"},"description":"This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. 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Castellanos","url":"https://profiles.ucsf.edu/maria.castellanos"}] </script> </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>