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

Part of paid clinical trials in Orange, California.

Sponsor
Children's Hospital of Orange County
Study ID
NCT05501899
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Levocarnitine — DRUG
    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)

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment Arm (single arm)

Primary Outcome Measure

Primary Outcome #1 [ Time Frame: 1.5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Deepa Jeyakumar, MD
[email protected]
714-456-5153
Children's Hospital of Orange CountyOrangeCalifornia92868
Van T. Huynh, M.D.
[email protected]
714-509-4348
Van T. Huynh, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CAChildren's Hospital of Orange County· Orange, CA

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