NCT05602194
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Active, Not Recruiting
PHASE3Ages 15–40InterventionalSupportive careChildren's Oncology GroupGovernment-funded
~440 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCalaspargase PegolLevocarnitinePegaspargaseQuality-of-Life Assessment
At a glance
Recruiting sites
0 of 228 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of conjugated hyperbilirubinemia > 3 mg/dL during induction therapy
Measured over During induction therapy (up-to 35-days after initiating induction chemotherapy)
Conditions
Where it's being run
228 sites across 44 statesNevada36
Wisconsin21
Michigan20
California19
Texas14
Florida13
New York12
Illinois7
Study leadership
- Etan Orgel · PRINCIPAL_INVESTIGATOR · Children's Oncology Group
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
\>= 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):
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
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
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
What this trial measures
- Incidence of conjugated hyperbilirubinemia > 3 mg/dL during induction therapyDuring induction therapy (up-to 35-days after initiating induction chemotherapy)
For patients assigned to arms A and B, the investigators will separately estimate the proportion of patients who experience conjugated hyperbilirubinemia \> 3mg/dL during induction chemotherapy by arm along with corresponding 95% confidence intervals.