Using Levocarnitine to Reduce Liver Damage from Chemotherapy in Young Patients with Leukemia
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
This study is testing if giving levocarnitine to children and young adults with leukemia can help protect their livers from damage caused by chemotherapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years to 29 Years |
| Sex | All |
| Sponsor | Children's Hospital of Orange County Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Orange, California and 1 other locations) |
| Trial ID | NCT05501899 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of levocarnitine, a supplement derived from carnitine, to prevent liver damage caused by asparaginase in children and young adults diagnosed with acute lymphoblastic leukemia (ALL). The study aims to assess whether administering levocarnitine during critical treatment phases can reduce hepatotoxicity and explore the relationship between ethnicity and liver function abnormalities. Additionally, it will investigate the impact of obesity on liver dysfunction and monitor other potential toxicities associated with asparaginase treatment. Participants will be treated according to a Children's Oncology Group protocol, and their liver function will be closely monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults aged 5 to 30 years who have been newly diagnosed with high-risk acute lymphoblastic leukemia.
Not a fit: Patients with known allergies to levocarnitine, severely compromised renal function, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce liver toxicity in young patients undergoing treatment for leukemia, improving their overall health outcomes.
How similar studies have performed: While the use of levocarnitine in this context is novel, previous studies have indicated its potential benefits in reducing oxidative stress and inflammation, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orange, California and 1 other locations
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (Recruiting)
- Children's Hospital of Orange County — Orange, California, United States (Recruiting)
Study contacts
- Study coordinator: Van T. Huynh, M.D.
- Email: vahuynh@choc.org
- Phone: (714) 509-4348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.