Actively Recruiting
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Led by Children's Hospital of Orange County · Updated on 2024-08-21
20
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Orange County
Lead Sponsor
U
University of California, Irvine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 5 to less than 30 years
- Newly diagnosed with acute lymphoblastic leukemia (ALL) classified as high-risk
- Treatment following a Children's Oncology Group (COG) protocol for ALL
- Ability and willingness to take oral medications including levocarnitine
You will not qualify if you...
- Known allergy to levocarnitine or its components
- Severely compromised kidney function or end-stage renal disease
- Pregnancy or breastfeeding
- Current treatment with warfarin
- History of seizures before ALL diagnosis
- Known inherited metabolic disorders
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
Research Team
V
Van T. Huynh, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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