NCT05501899 Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
| NCT ID | NCT05501899 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital of Orange County |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-03-03 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05501899 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 29 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05501899 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05501899 currently recruiting?
Yes, NCT05501899 is actively recruiting participants. Contact the research team at vahuynh@choc.org for enrollment information.
Where is the NCT05501899 trial being conducted?
This trial is being conducted at Orange, United States, Orange, United States.
Who is sponsoring the NCT05501899 clinical trial?
NCT05501899 is sponsored by Children's Hospital of Orange County. The trial plans to enroll 20 participants.
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