Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

Inclusion Criteria:

• >= 15 and < 40 years at time of diagnosis

• Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acuteleukemia/lymphoma (MPAL)

• Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors [TKI] or CRLF2- targeted concomitantmedication must be documented, if used)

• Conjugated bilirubin =< 1.5 x upper limit of normal (ULN) for age, regardless ofbaseline bilirubin (within 7 days prior to enrollment), and

• Serum glutamate pyruvate transaminase (SGPT) (ALT) =< 225 U/L (=< 5x ULN) (within 7days prior to enrollment), and

• Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to thevalue of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50U/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 thevalue of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline

• For patients receiving ursodiol prior to enrollment, laboratory values must meetabove 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 priorto enrollment) OR

• A glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2. GFR must be performedusing 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 KidneyFoundation athttps://www.kidney.org/professionals/kdoqi/gfr_calculatorped

• Measured GFR >= 30 mL/min/1.73 m^2 (any age). If measured GFR is used, itmust be performed using direct measurement with a nuclear blood samplingmethod or small molecule clearance method (iothalamate or other moleculeper institutional standard)

• ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance >= 30 mL/min, asestimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7days prior to enrollment). Estimated creatinine clearance is based on actual bodyweight

• An online calculator is available through the National Kidney Foundation athttps://www.kidney.org/professionals/kdoqi/gfr_calculatorcoc

• Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-basedInduction regimen and must be inclusive of >= 1 dose of pegaspargase or calaspargasepegol, and

• First dose of asparaginase must be planned within the first week of inductiontherapy, and

• Dose of pegaspargase or calaspargase pegol must be >= 1,000 IU/ m^2 (dose-cappingpermitted 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 informedconsent

• 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 noteligible

• The following are permitted: steroid prophase, hydroxyurea, or othercytoreduction prior to initiation of Induction chemotherapy (must bedocumented) and chemotherapy for current diagnosis (i.e. initiation ofInduction therapy within enrollment window). Chemotherapy prior to enrollmentfor treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmunedisease) is also permitted and must be documented

• Female patients who are pregnant since fetal toxicities and teratogenic effects inhumans are unknown for study drug. A pregnancy test is required for female patientsof childbearing potential

• Lactating females who plan to breastfeed their infants

• Sexually active patients of reproductive potential who have not agreed to use aneffective contraceptive method for the duration of their study participation