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

Phase 1

Recruiting

• Conditions: Acute Lymphoblastic Leukemia; Hepatotoxicity

• Registration Number: NCT05501899
• Lead Sponsor: Children's Hospital of Orange County

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-8-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients aged 5 to < 30 years<br><br> - Newly diagnosed with ALL designated as NCI high-risk (HR) ALL<br><br> - Treatment for ALL to be according to a Children's Oncology Group (COG) treatment<br> protocol (on study or according to study)<br><br> - Ability to take oral medications and willing to adhere to the levocarnitine regimen<br><br>Exclusion Criteria:<br><br> - Known allergic reaction to levocarnitine or its components<br><br> - Presence of severely compromised renal function or end-stage renal disease<br><br> - Pregnancy or lactation<br><br> - Warfarin therapy<br><br> - History of seizures prior to ALL diagnosis<br><br> - Known inborn error of metabolism

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome #1;Primary Outcome #2

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome #1;Secondary Outcome #2;Secondary Outcome #3;Secondary Outcome #4