An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

Inclusion Criteria:

1. Have a diagnosis of ALL or LBL

2. Be 18 to <40 years of age at the time of enrollment

3. Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli
asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)

4. Have the following asparaginase doses remaining in their treatment plan:

- At least two (2) consecutive weeks of native E. coli asparaginase treatment OR

- At least one (1) dose of pegaspargase (Oncaspar)

5. Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])

6. Have amylase and lipase within normal limits (per institutional standards)

7. Have a serum asparaginase activity below the detectable limit during screening prior
to the first dose of study drug (Erwinaze)

8. Consent to use a medically acceptable method of contraception throughout the entire
study period and for 4 weeks after the study is completed. Medically acceptable
methods of contraception that may be used by the subject and/or the partner include
abstinence, birth control pills or patches, diaphragm and spermicide, condom and
vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months
prior to baseline), and progestin implant or injection.

9. Have signed informed consent

Exclusion Criteria:

1. Prior history of ≥ Grade 3 pancreatitis

2. Prior history of a major thrombotic event as assessed by the investigator, or any
subject with a history of asparaginase-associated serious hemorrhagic or thrombotic
event requiring prolonged anticoagulation therapy with agents such as heparin

3. Prior treatment with Erwinaze

4. Pregnant or lactating female subjects or female subjects of childbearing potential
not willing to use an adequate method of birth control (listed above) for the
duration of the study

5. Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.

6. Any other condition that would cause a risk (in the investigator's judgment) to
subjects if they participate in the trial