Actively Recruiting

Early Phase 1
Age: 5Years - 29Years
All Genders
NCT05501899

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

Age: 5Years - 29Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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