Levocarnitine for Hepatotoxicity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA
Hepatotoxicity+4 More
Levocarnitine - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Hepatotoxicity
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatotoxicity

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 1.5 years

1.5 years
#1
#1
#2
#2
#3
#4

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatotoxicity

Trial Design

1 Treatment Group

Treatment Arm (single arm)
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Levocarnitine · No Placebo Group · Phase < 1

Treatment Arm (single arm)
Drug
Experimental Group · 1 Intervention: Levocarnitine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levocarnitine
1996
Completed Phase 3
~510

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1.5 years
Closest Location: Chao Family Comprehensive Cancer Center, University of California, Irvine · Orange, CA
Photo of Orange 1Photo of Orange 2Photo of Orange 3
2011First Recorded Clinical Trial
1 TrialsResearching Hepatotoxicity
4 CompletedClinical Trials

Who is running the clinical trial?

University of California, IrvineOTHER
486 Previous Clinical Trials
1,874,280 Total Patients Enrolled
Children's Hospital of Orange CountyLead Sponsor
26 Previous Clinical Trials
4,586 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have ALL and are newly diagnosed.
You are able to take oral medications and willing to adhere to the levocarnitine regimen.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References