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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of levocarnitine in combination with vitamin B complex in treating PEG-asparaginase (PEG) or inotuzumab ozogamicin (INO) induced hyperbilirubinemia (total bilirubin [Tbili] > 3 x upper limit of normal [ULN]) in patients (pts) 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03564678
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Elias Jabbour, MD
Phone 713-792-4764
Email ejabbour@mdanderson.org
Status Recruiting
Phase Phase 2
Start date May 17, 2018
Completion date December 31, 2036

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