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

Recruiting now · Early Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Hepatotoxicity

In brief

Acute lymphoblastic leukemia (ALL) is the most common cancer seen in pediatric oncology. The necessary chemotherapy for pediatric and adolescent and young adult (AYA) patients with ALL includes steroids, anthracyclines, asparaginase, and vincristine. One of the most hepatotoxic chemotherapy agents is asparaginase, with treatment-associated hepatotoxicity (TAH) observed in up to 60% of patients. The frequency of TAH is increased in overweight or obese patients of Latino heritage. Carnitine is a naturally-derived compound that is produced in the liver and kidneys; it is found in certain foods, such as meat, poultry, fish, and some dairy products. Endogenous carnitine transports long-chain fatty acids into the mitochondria, where they are oxidized to produce energy, and acts as scavengers of oxygen free radicals. Thus, carnitine can reduce oxidative stress and modulate inflammatory response. Levocarnitine is a supplement form of carnitine used typically in the care and management of patients with carnitine deficiency. Pediatric and AYAs with ALL will be given oral levocarnitine as a supplement during their initial phases of treatment, when the most hepatotoxic agents are administered, to determine if the incidence of liver toxicity can be reduced or eliminated.

Key facts

Study ID

NCT05501899

Run by

Children's Hospital of Orange County

People needed

20

Starts

2023-03-03

Expected to finish

2024-12-31

Last updated by the study team

2024-08-21

Who can join

Age: 5 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)

Full record on ClinicalTrials.gov

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