RecruitingEarly Phase 1NCT05501899

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


Sponsor

Children's Hospital of Orange County

Enrollment

20 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called levocarnitine can protect the liver from damage caused by asparaginase, a chemotherapy drug commonly used to treat acute lymphoblastic leukemia (ALL) — a blood cancer — in children and young adults. **You may be eligible if...** - You are between 5 and 29 years old - You have been newly diagnosed with high-risk ALL - You are being treated according to a Children's Oncology Group (COG) protocol - You are able to take oral medication **You may NOT be eligible if...** - You have a known allergy to levocarnitine - You have severe kidney disease - You are pregnant or breastfeeding - You take warfarin (a blood thinner) - You have a history of seizures before your ALL diagnosis - You have an inherited metabolic disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevocarnitine

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)


Locations(2)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Children's Hospital of Orange County

Orange, California, United States

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NCT05501899


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