About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Known allergic reaction to levocarnitine or its components
Presence of severely compromised renal function or end-stage renal disease
Pregnancy or lactation
Warfarin therapy
Trial design
Treatments tested in this trial
- Levocarnitine
Treatment groups
Sponsors and collaborators
Children's Hospital of Orange County
Lead sponsor
University of California, Irvine
Collaborator