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OncoMatch/Clinical Trials/NCT05501899

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

Is NCT05501899 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Levocarnitine for acute lymphoblastic leukemia.

Early Phase 1RecruitingChildren's Hospital of Orange CountyNCT05501899Data as of May 2026

Treatment: LevocarnitineAcute 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.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Prior therapy

No prior treatment (treatment-naive required)

Lab requirements

Kidney function

No severely compromised renal function or end-stage renal disease

Presence of severely compromised renal function or end-stage renal disease [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Chao Family Comprehensive Cancer Center, University of California, Irvine · Orange, California
  • Children's Hospital of Orange County · Orange, California

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