This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. Vitamin B complex is a dietary supplement that may be used for patients with nutritional deficiencies. Giving levocarnitine and vitamin B complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03564678.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of levocarnitine in combination with vitamin B complex in treating polyethylene glycol (PEG)-asparaginase or inotuzumab ozogamicin induced hyperbilirubinemia (total bilirubin > 3 x upper limit of normal [ULN]) in patients with acute lymphoblastic leukemia (ALL).
SECONDARY OBJECTIVES:
I. To evaluate chemotherapy dose intensity in patients treated with PEG-asparaginase or inotuzumab ozogamicin.
II. To characterize the safety, tolerability, and adverse event profile of levocarnitine and vitamin B for the treatment of hyperbilirubinemia.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
Patients receive levocarnitine intravenously (IV) over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or orally (PO) three times a day (TID) (outpatient). Patients also receive vitamin B complex PO twice daily (BID). Treatment continues for up to 30 days after the last dose of either PEG-asparaginase or inotuzumab, or until Tbili of =< 1.5 x ULN or at least a 50% reduction in peak Tbili is achieved.
After completion of study treatment, patients are followed up at 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorElias Jabbour
