Pediatric Clinical Trials
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy 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.
Stanford is currently accepting patients for this trial.
Intervention(s):
- procedure: Biospecimen Collection
- drug: Calaspargase Pegol
- dietary supplement: Levocarnitine
- drug: Pegaspargase
- other: Quality-of-Life Assessment
Eligibility
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
Ages Eligible for Study
15 Years - 40 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mani Gupta
650-723-0501
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