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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Orange County
• Collaborator: University of California, Irvine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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