RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-03
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05501899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 5 to \< 30 years
  2. * Newly diagnosed with ALL designated as NCI high-risk (HR) ALL
  3. * Treatment for ALL to be according to a Children's Oncology Group (COG) treatment protocol (on study or according to study)
  4. * Ability to take oral medications and willing to adhere to the levocarnitine regimen
  1. * Known allergic reaction to levocarnitine or its components
  2. * Presence of severely compromised renal function or end-stage renal disease
  3. * Pregnancy or lactation
  4. * Warfarin therapy
  5. * History of seizures prior to ALL diagnosis
  6. * Known inborn error of metabolism

Contacts and Locations

Study Contact

Van T. Huynh, M.D.
CONTACT
(714) 509-4348
vahuynh@choc.org

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
United States
Children's Hospital of Orange County
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Orange County

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-03-03
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Hepatotoxicity