Levocarnitine for Liver Toxicity in Acute Lymphoblastic Leukemia

Recruiting at 1 trial location

Overseen By Van T. Huynh, M.D.

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Orange County

Must be taking: Levocarnitine

Must not be taking: Warfarin

Disqualifiers: Severe renal disease, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of 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

This trial is for patients aged 5 to under 30 years who have been newly diagnosed with high-risk Acute Lymphoblastic Leukemia (ALL) and are following a Children's Oncology Group treatment protocol. They must be able to take oral medication and follow the levocarnitine regimen. Excluded are those allergic to levocarnitine, on warfarin therapy, with metabolic disorders, severe kidney issues, pregnant or lactating women, or with a history of seizures before ALL diagnosis.

Inclusion Criteria

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)

Patients aged 5 to < 30 years

Exclusion Criteria

Presence of severely compromised renal function or end-stage renal disease

Pregnancy or lactation

You have had seizures before being diagnosed with ALL (acute lymphoblastic leukemia).

Treatment Details

Interventions

• Levocarnitine

Trial Overview The study tests if Levocarnitine can reduce liver toxicity in pediatric and young adult patients undergoing chemotherapy for ALL. Participants will receive oral Levocarnitine during initial treatment phases where hepatotoxic agents like asparaginase are most commonly used.

Participant Groups

Group I: Treatment Arm (single arm) Experimental Treatment 1 Intervention

Levocarnitine is already approved in United States, European Union for the following indications:

Approved in United States as Carnitor for:

• Carnitine deficiency
• Hyperlipoproteinemia

Approved in European Union as Levocarnitine for:

• Carnitine deficiency
• Hyperlipoproteinemia

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials

38

Recruited

5,700+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+