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Levocarnitine for Asparaginase Hepatotoxicity in ALL

This study is looking at whether a medication called levocarnitine can help reduce liver problems (hepatotoxicity) in children and young adults (ages 5-29) who are being treated for a type of blood cancer called Acute Lymphoblastic Leukemia (ALL). Asparaginase, a common chemotherapy drug for ALL, can cause liver damage in many patients. Levocarnitine is a natural compound found in some foods. Participants will take levocarnitine by mouth twice a day during certain phases of their ALL treatment. The study aims to see if this reduces liver problems and if it affects how well the ALL treatment works. It also explores if ethnicity or being overweight impacts liver function during treatment. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment (levocarnitine). It aims to enroll 20 participants.
What's involved
You would take levocarnitine by mouth twice a day during specific phases of your ALL treatment. The study does not detail other specific visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured at 1.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05501899

Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia

UNKNOWN
EARLY_PHASE1Ages 5–29InterventionalSupportive care
Children's Hospital of Orange County
~20 participants
Updated 2024-08-21 on ClinicalTrials.gov
What's tested:Levocarnitine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome #1
Measured over 1.5 years
+1 more outcome measured

Conditions

Acute Lymphoblastic Leukemia
Hepatotoxicity

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Acute Lymphoblastic Leukemia

NCT05501899

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, Californiastudy coordinator listed

    Recruiting

  • Children's Hospital of Orange County

    Orange, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Van T. Huynh, M.D.
[email protected]
(714) 509-4348
Email the study team

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Eligibility criteria

Inclusion

Patients aged 5 to \< 30 years
Newly diagnosed with ALL designated as NCI high-risk (HR) ALL
Treatment for ALL to be according to a Children's Oncology Group (COG) treatment protocol (on study or according to study)
Ability to take oral medications and willing to adhere to the levocarnitine regimen

Exclusion

Known allergic reaction to levocarnitine or its components
Presence of severely compromised renal function or end-stage renal disease
Pregnancy or lactation
Warfarin therapy
History of seizures prior to ALL diagnosis
Known inborn error of metabolism

What this trial measures

  • Primary Outcome #11.5 years

    Calculate proportion of patients who experience hepatotoxicity, as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade ≥ 3 elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total and direct bilirubin.

  • Primary Outcome #21.5 years

    Calculate prevalence of hepatotoxicity in patients who self-identify as Latino or non-Latino, using laboratory assessments and self-reported measures of ethnicity and/or race.