Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia

What Was Tested

In this phase 2 trial, researchers set out to test L-Carnitine.

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.

It had 1 arm (groups): Treatment (levocarnitine, vitamin B complex) (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

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).

After completion of study treatment, patients are followed up at 30 days.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients at least 18 years of age. Non-English speakers may be enrolled. Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or inotuzumab ozogamicin with Tbili \> 3 x ULN. Signed informed consent.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: pregnant or nursing women; known hypersensitivity to levocarnitine or vitamin b complex.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the L-Carnitine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-05-17 with completion listed for 2024-10-15.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of Participants With a Response (time frame: Up to 11 days).

What This Means in Plain Language

Put simply, this is a phase 2 trial of L-Carnitine in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, all human trials.