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Supplement

Levocarnitine for Liver Toxicity in Acute Lymphoblastic Leukemia

Phase < 1
Recruiting
Research Sponsored by Children's Hospital of Orange County
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the supplement levocarnitine can reduce the incidence of liver toxicity in pediatric and AYA patients with ALL being treated with the most hepatotoxic agents.

Who is the study for?
This trial is for patients aged 5 to under 30 years who have been newly diagnosed with high-risk Acute Lymphoblastic Leukemia (ALL) and are following a Children's Oncology Group treatment protocol. They must be able to take oral medication and follow the levocarnitine regimen. Excluded are those allergic to levocarnitine, on warfarin therapy, with metabolic disorders, severe kidney issues, pregnant or lactating women, or with a history of seizures before ALL diagnosis.
What is being tested?
The study tests if Levocarnitine can reduce liver toxicity in pediatric and young adult patients undergoing chemotherapy for ALL. Participants will receive oral Levocarnitine during initial treatment phases where hepatotoxic agents like asparaginase are most commonly used.
What are the potential side effects?
Levocarnitine may cause side effects such as nausea, vomiting, abdominal cramps, diarrhea, 'fishy' body odor in some individuals; however it is generally considered safe when used as directed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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Secondary study objectives
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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 Arm (single arm)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levocarnitine
1996
Completed Phase 3
~510

Find a Location

Who is running the clinical trial?

University of California, IrvineOTHER
561 Previous Clinical Trials
1,932,119 Total Patients Enrolled
Children's Hospital of Orange CountyLead Sponsor
34 Previous Clinical Trials
5,257 Total Patients Enrolled

Media Library

Levocarnitine (Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05501899 — Phase < 1
Acute Lymphoblastic Leukemia Research Study Groups: Treatment Arm (single arm)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Levocarnitine Highlights & Side Effects. Trial Name: NCT05501899 — Phase < 1
Levocarnitine (Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501899 — Phase < 1
~1 spots leftby Dec 2024
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