Gender
All
Age Group
15 Years to 40 Years
Accepting Healthy Volunteers
No
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
- 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):
-
1. 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
-
2. 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 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 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