← Back to Search

Amino Acid

Levocarnitine + Vitamin B Complex for Jaundice in Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Elias Jabbour

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or inotuzumab ozogamicin with Tbili > 3 x ULN

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after completion of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of levocarnitine and vitamin B complex in treating patients with high liver enzyme levels caused by cancer treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to levocarnitine such as nausea, vomiting, stomach upset, heartburn, diarrhea, and seizures; and from vitamin B complex like excessive thirst, skin conditions, blurry vision, abdominal cramps, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rates

Secondary study objectives

Evaluation of chemotherapy dose intensity

Incidence of adverse events

Other study objectives

Time to hyperbilirubinemia normalization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (levocarnitine, vitamin B complex)Experimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levocarnitine

1996

Completed Phase 3

~510

Vitamin B Complex

2011

Completed Phase 3

~100