OncoMatch/Clinical Trials/NCT05602194
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Is NCT05602194 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Calaspargase Pegol and Pegaspargase for b acute lymphoblastic leukemia.
Treatment: Calaspargase Pegol · Pegaspargase — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Biomarker criteria
Allowed: BCR fusion
Philadelphia chromosome (PH)+ ... eligible
Allowed: ABL1 fusion
Philadelphia chromosome (PH)+ ... eligible
Allowed: CRLF2 overexpression
CRLF2-targeted concomitant medication must be documented, if used
Prior therapy
Cannot have received: chemotherapy
Exception: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented); 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
Patients who received chemotherapy or treatment for a prior malignancy are not eligible
Lab requirements
Kidney function
Pediatric (15-17): 24-hour urine creatinine clearance >= 30 mL/min/1.73 m^2 OR GFR >= 30 mL/min/1.73 m^2 (estimated or measured); Adult (>=18): Creatinine clearance >= 30 mL/min (Cockcroft-Gault or 24-hour urine)
Liver function
Conjugated bilirubin <= 1.5 x ULN for age; SGPT (ALT) <= 225 U/L (<= 5x ULN); SGOT (AST) <= 250 U/L (<= 5x ULN); for study, ULN for SGPT (ALT) = 45 U/L, SGOT (AST) = 50 U/L
Conjugated bilirubin <= 1.5 x ULN for age, SGPT (ALT) <= 225 U/L (<= 5x ULN), SGOT (AST) <= 250 U/L (<= 5x ULN); Pediatric: 24-hour urine creatinine clearance >= 30 mL/min/1.73 m^2 OR GFR >= 30 mL/min/1.73 m^2; Adult: Creatinine clearance >= 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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