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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 29
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Chao Family Comprehensive Cancer Center, University of California, Irvine
RECRUITING
Orange
Children's Hospital of Orange County
RECRUITING
Orange
Contact Information
Primary
Van T. Huynh, M.D.
vahuynh@choc.org
(714) 509-4348
Time Frame
Start Date: 2023-03-03
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Treatment Arm (single arm)
Sponsors
Collaborators: University of California, Irvine
Leads: Children's Hospital of Orange County

This content was sourced from clinicaltrials.gov