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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
NCT05602194 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- DRUG Calaspargase Pegol
- DIETARY_SUPPLEMENT Levocarnitine
- DRUG Pegaspargase
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- PCR Oncology — Arroyo Grande
- Kaiser Permanente-Bellflower — Bellflower
- Kaiser Permanente Downey Medical Center — Downey
- City of Hope Comprehensive Cancer Center — Duarte
- Kaiser Permanente-Fontana — Fontana
- Loma Linda University Medical Center — Loma Linda
- Miller Children's and Women's Hospital Long Beach — Long Beach
- Children's Hospital Los Angeles — Los Angeles
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Valley Children's Hospital — Madera
- UCSF Benioff Children's Hospital Oakland — Oakland
- Lucile Packard Children's Hospital Stanford University — Palo Alto
- Stanford Cancer Institute Palo Alto — Palo Alto
Arizona
- Kingman Regional Medical Center — Kingman
- Phoenix Childrens Hospital — Phoenix
- Banner University Medical Center - Tucson — Tucson
Alabama
- Children's Hospital of Alabama — Birmingham
Alaska
- Providence Alaska Medical Center — Anchorage
Arkansas
- Arkansas Children's Hospital — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05602194
The ClinicalTrials.gov registry entry for NCT05602194 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05602194 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05602194 about?
NCT05602194 is a clinical study titled "Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma". 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 leukemi...
What is the current status of trial NCT05602194?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2023-08-14. Estimated completion is 2028-12-30.
What conditions does trial NCT05602194 study?
This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, Lymphoblastic Lymphoma, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, T Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05602194?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Calaspargase Pegol (DRUG), Levocarnitine (DIETARY_SUPPLEMENT), Pegaspargase (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05602194?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05602194 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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