This early phase I trial tests the safety, side effects, and effectiveness of levocarnitine given during induction and consolidation therapy for patients with acute lymphoblastic leukemia (ALL) to decrease the risk of liver damage (hepatotoxicity) caused by chemotherapy. ALL is the most common childhood malignancy. The incorporation of asparaginase, along with risk-directed therapy and improved supportive care, has contributed to significant improvements in outcomes for children with ALL. Unfortunately, not all children have benefited equally from improved therapy. A large disparity in overall survival exists, with Latino children and adolescents and young adults (AYAs) experiencing less favorable outcomes. The necessary chemotherapy for pediatric-based treatment regimens for ALL includes steroids, anthracyclines, asparaginase, and vincristine, all of which are intensive and toxic. One of the most hepatotoxic chemotherapy agents is asparaginase. Levocarnitine is a diet supplement used to prevent and treat low blood levels of carnitine. Carnitine is a substance made in the body from meat and dairy products. It helps the body use certain chemicals (long-chain fatty acids) for energy and to keep people in good health. Carnitine is also an antioxidant meaning that it protects cells from damage caused by free radicals (unstable molecules made by the process of oxidation during normal metabolism). The information gained from this trial will help researchers determine whether levocarnitine supplementation reduces the incidence of hepatotoxicity in patients receiving induction and consolidation therapy for ALL.
Additional locations may be listed on ClinicalTrials.gov for NCT05501899.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Active
Contact: Deepa Jeyakumar
Phone: 714-456-5153
Children's Hospital of Orange CountyStatus: Active
Contact: Van Thu Huynh
Phone: 714-509-4348
PRIMARY OBJECTIVES:
I. Prospectively evaluate whether the prophylactic use of levocarnitine during induction and consolidation (phases with asparaginase therapy) in ALL patients receiving treatment according to a Children's Oncology Group (COG) treatment protocol reduces hepatotoxicity.
II. Demonstrate an association between ethnicity and liver function test abnormalities in children and AYAs with ALL. Specifically, that Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade >= 3 elevated liver function tests is more prevalent in self-identified Latinos as compared to other ethnicities in a retrospective control group.
SECONDARY OBJECTIVES:
I. Determine whether obesity or overweight status, as measured by body mass index, at diagnosis increases the risk of hepatic dysfunction.
II. Quantify the disease response, based on the end of Induction minimal residual disease (MRD) in the bone marrow of patients receiving levocarnitine, compared to historical controls to determine that levocarnitine does not have a negative impact on MRD.
III. Assess incidence of nonalcoholic fatty liver disease (NAFLD), via non-invasive ultrasound elastography, in pediatric and AYA patients newly diagnosed with ALL.
IV. Assess incidence of other known toxicities of asparaginase treatment, including hyper/hypoglycemia, hypertriglyceridemia, pancreatitis, and thrombosis that are CTCAE version 5.0 grade >= 3 with onset =< 30 days (or next dose if sooner) of asparaginase.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I (PROSPECTIVE CASES): Patients receive levocarnitine orally (PO) during induction and consolidation therapy on study and undergo blood sample collection during screening and follow-up. Patients may also optionally undergo ultrasound elastography during screening or on study.
GROUP II (RETROSPECTIVE CONTROL CASES): Patients undergo data collection with review of medical records on study.
Patients are followed up to 14 days after the final dose of levocarnitine.
Trial PhasePhase O
Trial Typesupportive care
Lead OrganizationChildren's Hospital of Orange County
Principal InvestigatorVan Thu Huynh
