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Supplement

Levocarnitine for Liver Toxicity in Acute Lymphoblastic Leukemia

Q: Is the enrollment period ongoing for this investigation?

Per clinicaltrials.gov, the recruitment period for this trial is closed at present. Though initially advertised on September 1st 2022 and last updated on August 12th 2022, the study is not currently enrolling patients; however there are 1498 other trials that require volunteers right now.

Q: Who qualifies to participate in this research project?

This medical trial has a limited capacity of 20 people aged between 5 and 29 years who are currently experiencing hepatotoxicity. The inclusion criteria also require patients to meet the following conditions: newly diagnosed with NCI high-risk <a href="https://www.withpower.com/clinical-trials/all">ALL</a>, treatment according to Children's <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group protocol (on study or according to study), ability to take oral medications and willingness to follow levocarnitine regimen.

Q: Is this research trial available to adult participants?

This clinical research demands that prospective patients are aged between 5 and 29. Meanwhile, 465 trials exist for individuals under 18 while 1190 slots are available to those over 65.

Q: What primary purpose does this trial strive to fulfill?

The primary aim of this experiment, over the course of eighteen months, is to assess Primary Outcome #1. Secondary objectives consist of ascertaining Secondary Outcome #1 (establishing risk factors for hepatotoxicity among <a href="https://www.withpower.com/clinical-trials/overweight">overweight</a> or obese individuals at diagnosis), Secondaray Outcome #2 (evaluating disease response with end-of-induction minimal residual disease results) and Secondary Objective #4 (calculating proportion of patients experiencing asparaginase treatment toxicities).

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Secondary outcome measures

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, IrvineOTHER

542 Previous Clinical Trials

1,921,981 Total Patients Enrolled

Children's Hospital of Orange CountyLead Sponsor

32 Previous Clinical Trials

4,914 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period ongoing for this investigation?

"Per clinicaltrials.gov, the recruitment period for this trial is closed at present. Though initially advertised on September 1st 2022 and last updated on August 12th 2022, the study is not currently enrolling patients; however there are 1498 other trials that require volunteers right now."

Answered by AI

Who qualifies to participate in this research project?

"This medical trial has a limited capacity of 20 people aged between 5 and 29 years who are currently experiencing hepatotoxicity. The inclusion criteria also require patients to meet the following conditions: newly diagnosed with NCI high-risk ALL, treatment according to Children's Oncology Group protocol (on study or according to study), ability to take oral medications and willingness to follow levocarnitine regimen."

Answered by AI

Is this research trial available to adult participants?

"This clinical research demands that prospective patients are aged between 5 and 29. Meanwhile, 465 trials exist for individuals under 18 while 1190 slots are available to those over 65."

Answered by AI

What primary purpose does this trial strive to fulfill?

"The primary aim of this experiment, over the course of eighteen months, is to assess Primary Outcome #1. Secondary objectives consist of ascertaining Secondary Outcome #1 (establishing risk factors for hepatotoxicity among overweight or obese individuals at diagnosis), Secondaray Outcome #2 (evaluating disease response with end-of-induction minimal residual disease results) and Secondary Objective #4 (calculating proportion of patients experiencing asparaginase treatment toxicities)."

Answered by AI

Recent research and studies

BloodJournal

How I Treat the Toxicities of Pegasparaginase in Adults with Acute Lymphoblastic Leukemia

Aldoss, Ibrahim, and Dan Douer. 2020. “How I Treat the Toxicities of Pegasparaginase in Adults with Acute Lymphoblastic Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood.2019002477.

BloodJournal

A Pediatric Regimen for Older Adolescents and Young Adults with Acute Lymphoblastic Leukemia: Results of CALGB 10403

Stock, Wendy, Selina M. Luger, Anjali S. Advani, Jun Yin, Richard C. Harvey, Charles G. Mullighan, Cheryl L. Willman, et al.. 2019. “A Pediatric Regimen for Older Adolescents and Young Adults with Acute Lymphoblastic Leukemia: Results of CALGB 10403”. Blood. American Society of Hematology. doi:10.1182/blood-2018-10-881961.

Journal of Clinical OncologyJournal

Improved Survival for Children and Adolescents with Acute Lymphoblastic Leukemia Between 1990 and 2005: A Report from the Children's Oncology Group

Hunger, Stephen P., Xiaomin Lu, Meenakshi Devidas, Bruce M. Camitta, Paul S. Gaynon, Naomi J. Winick, Gregory H. Reaman, and William L. Carroll. 2012. “Improved Survival for Children and Adolescents with Acute Lymphoblastic Leukemia Between 1990 and 2005: A Report from the Children's Oncology Group”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2011.37.8018.

Digestive Diseases and SciencesJournal