ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
Objective
Primary Aim: To determine in a randomized manner whether the addition of levocarnitine prophylaxis to asparaginase-containing regimens will decrease the incidence of conjugated hyperbilirubinemia (>3 mg/dL) during ALL induction therapy for adolescents and young adults (AYAs, age 15-39 years).
Secondary Aims: To examine the impact of levocarnitine prophylaxis on differences in the incidence of Grade ≥ 3 ALT or AST elevations during ALL Induction. To compare rates of minimal residual disease (MRD) positivity at end of Induction and describe MRD+ by end of Consolidation (EOC) in those receiving ALL Induction chemotherapy with and without levocarnitine.
