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

UVA Tracking #
HSR230425
Principal Investigator
Brian C Belyea
Contact
Contact Phone
Official Trial Title
ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
Study Description

The Pediatric Hematology/Oncology Division at the University of Virginia is conducting a clinical research study for pediatric and young adult patients who are receiving Acute Lymphoblastic Leukemia therapy. This phase III trial compares the effect of adding levocarnitine to chemotherapy versus chemotherapy alone in protecting the liver in patients with leukemia and lymphoma. 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. 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 the body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Taking levocarnitine may reduce the rate of severe liver damage caused by asparaginase chemotherapy in patients with leukemia and lymphoma.

Additional information can be found here: Study Details | Levocarnitine To Protect the Liver From Chemotherapy for Leukemia or Lymphoma | ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT 05602194)

Compensation

No Compensation