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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

NCT05602194 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.

Conditions

  • B Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
  • Lymphoblastic Lymphoma
  • Mixed Phenotype Acute Leukemia
  • T Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Calaspargase Pegol

Given standard of care calaspargase pegol

DIETARY_SUPPLEMENT

Levocarnitine

Given PO or IV

DRUG

Pegaspargase

Given standard of care pegaspargase

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Etan Orgel · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2028-06-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602194 on ClinicalTrials.gov