Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
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
About this trial
This is an interventional supportive care trial for B Acute Lymphoblastic Leukemia
Eligibility 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 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) 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
Sites / Locations
- Miller Children's and Women's Hospital Long BeachRecruiting
- Alfred I duPont Hospital for ChildrenRecruiting
- Golisano Children's Hospital of Southwest FloridaRecruiting
- Nemours Children's Clinic-JacksonvilleRecruiting
- AdventHealth OrlandoRecruiting
- Nemours Children's HospitalRecruiting
- Riley Hospital for ChildrenRecruiting
- Ascension Saint Vincent Indianapolis HospitalRecruiting
- Norton Children's HospitalRecruiting
- Ochsner Medical Center JeffersonRecruiting
- Maine Children's Cancer ProgramRecruiting
- Sinai Hospital of BaltimoreRecruiting
- C S Mott Children's HospitalRecruiting
- Bronson Battle CreekRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Spectrum Health Reed City HospitalRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Munson Medical CenterRecruiting
- University of Michigan Health - WestRecruiting
- Albany Medical CenterRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- NYU Winthrop HospitalRecruiting
- New York Medical CollegeRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- Oregon Health and Science UniversityRecruiting
- Children's Hospital of Pittsburgh of UPMCRecruiting
- Saint Francis HospitalRecruiting
- BI-LO Charities Children's Cancer CenterRecruiting
- Saint Francis Cancer CenterRecruiting
- East Tennessee Childrens HospitalRecruiting
- The Children's Hospital at TriStar CentennialRecruiting
- Dell Children's Medical Center of Central TexasRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- Covenant Children's HospitalRecruiting
- Children's Hospital of San AntonioRecruiting
- Methodist Children's Hospital of South TexasRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Providence Sacred Heart Medical Center and Children's HospitalRecruiting
- Mary Bridge Children's Hospital and Health CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Arm A (levocarnitine, standard of care chemotherapy)
Arm B (standard of care chemotherapy)
Arm C (rescue levocarnitine)
Patients receive levocarnitine PO or IV prior to standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.
Patients receive standard of care induction chemotherapy with pegaspargase or calaspargase pegol on study. Patients may also undergo blood sample collection during screening and on study.
Patients in Arms A and B who develop conjugated hyperbilirubinemia > 3 mg/dL during induction may receive levocarnitine rescue PO or IV supplementation until resolution of conjugated hyperbilirubinemia =< 3 mg/dL (or start of consolidation or the next treatment phase, whichever occurs first).