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Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiians, or are Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Similarly, patients with obesity are also at higher risk for liver damage from chemotherapy.
This study looks at how well the drug levocarnitine works to prevent liver damage when given to adolescents and young adults being treated with asparaginase chemotherapy for their leukemia or lymphoma.
Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by your body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Levocarnitine is well tolerated in adults receiving chemotherapy and when used to prevent liver damage for other diagnoses. Levocarnitine has also been approved by the U.S. Food and Drug Administration (FDA) as a safe and effective treatment in children for other diagnoses that affect the liver.
Participants will be randomized to one of two study arms. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.
Randomized participants will be followed from randomization until end of Induction (approximately Day 35). A rescue arm (Arm C) will be open to participants in Arm B who develop conjugated hyperbilirubinemia greater than 3 mg/dL during Induction and wish to start levocarnitine supplementation.
Total study participation will last approximately 4 years.
Inclusion Criteria:
Exclusion Criteria:
Detailed eligibility will be reviewed when you contact the study team.