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This record was last updated August 21, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Record History
MinorStart date: Aug 14, 2023 to Aug 24, 2023Study sites revised (228)v34Show 1 more changeShow less
MinorTrial status changed: Recruiting → Active, Not RecruitingSite details revised at 228 of 228 sitesv31Show 1 more changeShow less
Site details revised at 228 of 228 sites
MinorStudy sites: 229 to 228v30
Show 28 earlier versionsHide 28 earlier versions
MinorStart date: Aug 24, 2023 to Aug 14, 2023Site details revised at 5 of 229 sites · Eligibility criteria shortened, about 2 words · Study description expanded, about 5 wordsv29Show 3 more changesShow less
NotableTrial status: Active, Not Recruiting to RecruitingStudy sites: 197 to 203 · Eligibility criteria expanded, about 185 words · Study description expanded, about 63 wordsv21Show 3 more changesShow less
NotablePrimary completion date: Dec 31, 2027 to Jun 30, 2028Completion date: Dec 31, 2027 to Dec 30, 2028v20Show 1 more changeShow less
Completion date: Dec 31, 2027 to Dec 30, 2028
MinorRe-verified, no change to tracked fieldsv19
MinorTrial status: Recruiting to Active, Not RecruitingStudy sites: 192 to 197v18Show 1 more changeShow less
Study sites: 192 to 197
MinorStudy sites: 191 to 192v17
MinorStudy sites: 172 to 191v16
MinorStudy sites: 121 to 172v15
MinorStart date: Aug 14, 2023 to Aug 24, 2023v14
MinorStudy sites: 114 to 121v13
MinorStudy sites: 96 to 114v12
NotablePrimary and study completion dates: Dec 30, 2026 to Dec 31, 2027Study sites: 93 to 96v11Show 1 more changeShow less
Study sites: 93 to 96
MinorStudy sites: 64 to 93v10
MinorStudy sites: 53 to 64v9
MinorSecondary endpoints: details revised at 1 of 2 entriesv8
NotablePrimary endpoint revisedStudy sites: 50 to 53 · Secondary endpoints revised (2) · Study description expanded, about 1 word · 1 morev7Show 4 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingPrimary endpoint revised · Study sites: 0 to 29 · Start date changed from estimate of Oct 16, 2023 to Aug 14, 2023 · 2 morev4Show 5 more changesShow less
Primary endpoint revised
Study sites: 0 to 29
Start date changed from estimate of Oct 16, 2023 to Aug 14, 2023
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (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 acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (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.