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ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Clinical Trial Details

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.

  • Arm A will receive levocarnitine prophylaxis prior to initial pegaspargase or calaspargase pegol exposure through end of Induction.
  • Arm B will receive the standard of care without levocarnitine prophylaxis.

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.

Key Eligibility: 

Inclusion Criteria:

  1. Males and females between the ages of 15-40 years at time of diagnosis.
  2. Individuals must have a diagnosis of Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL).

Exclusion Criteria:

  1. Patients with Down Syndrome, a known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille Syndrome, primary sclerosing cholangitis, other), or a known biopsy (or imaging) proven severe liver fibrosis
  2. Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential.
  3. Patients who received chemotherapy or treatment for a prior malignancy are not eligible.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026578

ClinicalTrials.gov:

NCT05602194

Sponsor:

ACCL1931

Status

Not Yet Recruiting

Age Group

Adult , Pediatric

Sponsor