Recruiting
Early Phase 1

Levocarnitine

Sponsor:

Children's Hospital of Orange County

Code:

NCT05501899

Conditions

Acute Lymphoblastic Leukemia

Hepatotoxicity

Eligibility Criteria

Sex: All

Age: 5 - 29

Healthy Volunteers: Not accepted

Interventions

Levocarnitine

Study Details

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Hepatotoxicity

Study ID

NCT05501899

Start date

Mar 3, 2023

Status verified date

Aug, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 29

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Arm (single arm)

Interventions

Levocarnitine

Adults, or patients ≥ 50 kg: 990 mg PO (by mouth) bis in die (BID, twice a day) Children, or patients < 50 kg: 50 mg/kg/day PO divided BID (maximum daily dose of 2,000 mg)

Primary outcome measure

  • Primary Outcome #1 [ Time Frame: 1.5 years ]
  • Primary Outcome #2 [ Time Frame: 1.5 years ]

Central Contacts and Locations

Central contacts

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Van T. Huynh, M.D.

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2024-08-21.