Levocarnitine + Vitamin B Complex for Jaundice in Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Elias Jabbour

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with acute lymphoblastic leukemia who are experiencing high liver enzyme levels due to treatment with PEG-asparaginase or inotuzumab ozogamicin. Participants must have signed an informed consent and have a bilirubin level more than three times the upper limit of normal. Pregnant or nursing women, or those allergic to levocarnitine or vitamin B complex, cannot join.

Inclusion Criteria

Signed informed consent

I have ALL and am being treated with specific drugs, but my liver tests are high.

Exclusion Criteria

You are allergic to levocarnitine or vitamin B complex.

You are pregnant or breastfeeding.

Treatment Details

Interventions

• Levocarnitine (Amino Acid)
• Vitamin B Complex (Other)

Trial Overview The study is testing whether levocarnitine (an amino acid) and vitamin B complex can treat hyperbilirubinemia caused by certain leukemia treatments. The aim is to see if these supplements can normalize liver enzymes better than current practices.

Participant Groups

Group I: Treatment (levocarnitine, vitamin B complex) Experimental Treatment 2 Interventions

Patients receive levocarnitine IV over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or PO TID (outpatient). Patients also receive vitamin B complex PO 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.

Levocarnitine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Carnitor for:

• Carnitine deficiency
• Hyperlipoproteinemia

🇪🇺 Approved in European Union as Levocarnitine for:

• Carnitine deficiency
• Hyperlipoproteinemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References