Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma (NCT05602194)
A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 15 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (228 Sites)
Showing the first 25 of 228 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- Providence Alaska Medical Center — Anchorage, Alaska
- Kingman Regional Medical Center — Kingman, Arizona
- Phoenix Childrens Hospital — Phoenix, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Kaiser Permanente-Anaheim — Anaheim, California
- PCR Oncology — Arroyo Grande, California
- Kaiser Permanente-Bellflower — Bellflower, California
- Kaiser Permanente Downey Medical Center — Downey, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Kaiser Permanente-Fontana — Fontana, California
- Loma Linda University Medical Center — Loma Linda, California
- Miller Children's and Women's Hospital Long Beach — Long Beach, California
- Children's Hospital Los Angeles — Los Angeles, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- Valley Children's Hospital — Madera, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- Stanford Cancer Institute Palo Alto — Palo Alto, California
- Sutter Medical Center Sacramento — Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Kaiser Permanente-San Diego Mission — San Diego, California
- Kaiser Permanente-San Diego Zion — San Diego, California
- UCSF Medical Center-Mission Bay — San Francisco, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in B Acute Lymphoblastic Leukemia
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia — Birmingham, Alabama
- Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia — Duarte, California
- Study of CD19/CD22 Chimeric Antigen Receptor T Cells in Children & Young Adults w/ Recurrent or Refractory B Cell Malignancies — Palo Alto, California
- Comparing Inotuzumab Combined With Low Intensity Chemotherapy Plus Blinatumomab to Usual Chemotherapy Plus Blinatumomab in Older Adults With CD22+ B-cell Acute Lymphoblastic Leukemia — Birmingham, Alabama
- CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies — Palo Alto, California
Explore by condition: All B Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.