Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia

What Was Tested

This registered early phase 1 trial tested L-Carnitine.

Acute lymphoblastic leukemia (ALL) is the most common cancer seen in pediatric oncology.

The necessary chemotherapy for pediatric and adolescent and young adult (AYA) patients with ALL includes steroids, anthracyclines, asparaginase, and vincristine.

It had 1 arm (groups): Treatment Arm (single arm) (experimental).

The registry classes the interventions as drug.

More on the Plan

Specifically, that Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade ≥ 3 elevated liver function tests is more prevalent in self-identified Latinos as compared to other ethnicities in a retrospective control group.

Quantify the disease response, based on the end of Induction minimal residual disease (MRD) in the bone marrow of patients receiving levocarnitine, compared to historical controls to determine that levocarnitine does not have a negative impact on MRD. 3.

Assess incidence of nonalcoholic fatty liver disease (NAFLD), via non-invasive ultrasound elastography, in pediatric and AYA patients newly diagnosed with ALL. 4.

Study Design: The proposal is a non-randomized case-control pilot study that will use retrospective case-control data as comparison (i.e., control group).

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 5 years up to 29 years.

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

Examples of who could join: Patients aged 5 to \< 30 years. Newly diagnosed with ALL designated as NCI high-risk (HR) ALL. Ability to take oral medications and willing to adhere to the levocarnitine regimen.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: known allergic reaction to levocarnitine or its components; presence of severely compromised renal function or end-stage renal disease; pregnancy or lactation.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

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

It started in 2023-03-03 with completion listed for 2024-12-31.

It ran at 2 sites in United States (2).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Primary Outcome #1 (time frame: 1.5 years). Primary Outcome #2 (time frame: 1.5 years).

It also tracked 4 secondary outcomes, for example Secondary Outcome #1, Secondary Outcome #2, Secondary Outcome #3 and Secondary Outcome #4.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of L-Carnitine in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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