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Effect of Levocarnitine on Liver Protection During Chemotherapy for Leukemia or Lymphoma

A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

PHASE3 · Children's Oncology Group · NCT05602194

This study is testing if adding levocarnitine to standard chemotherapy can help protect the livers of young people with leukemia or lymphoma from damage during treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment440 (estimated)
Ages15 Years to 40 Years
SexAll
SponsorChildren's Oncology Group (network)
Drugs / interventionschemotherapy, methotrexate
Locations211 sites (Birmingham, Alabama and 210 other locations)
Trial IDNCT05602194 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates whether adding levocarnitine to standard chemotherapy can protect the liver from damage in patients with leukemia or lymphoma. The study focuses on adolescents and young adults aged 15-39 who are at risk for liver toxicity due to chemotherapy, particularly those with specific genetic backgrounds. Participants will be randomly assigned to receive either standard chemotherapy alone or chemotherapy with levocarnitine, and various liver function metrics will be monitored throughout the treatment. The trial aims to assess the incidence of liver-related complications and overall treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adolescents and young adults aged 15-39 with newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma, or mixed-phenotype acute leukemia.

Not a fit: Patients outside the age range of 15-39 or those with pre-existing severe liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce liver toxicity in young patients undergoing chemotherapy, improving their treatment outcomes.

How similar studies have performed: While the use of levocarnitine in this context is novel, previous studies have indicated potential benefits of carnitine supplementation in reducing chemotherapy-related toxicity.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* \>= 15 and \< 40 years at time of diagnosis
* Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL)

  * Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used)
* Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and
* Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and

  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline
* SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment)

  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline
* For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days
* PEDIATRIC PATIENTS (AGE 15-17 years):

  * A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
  * A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment):

    * 1. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2.

      * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr_calculatorped
    * 2. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard).
* ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight

  * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr_calculatorcoc
* Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and
* First dose of asparaginase must be planned within the first week of induction therapy, and
* Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen)

  * Note: Co-enrollment on a therapeutic consortia trial is not required
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Down syndrome
* Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other)
* Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3)
* Unable to tolerate oral formulation of study drug at enrollment
* Patients who received chemotherapy or treatment for a prior malignancy are not eligible

  * The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented
* Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Where this trial is running

Birmingham, Alabama and 210 other locations

+161 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9, 22)(q34.1, q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.