An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase® (crisantaspase) Administered Following Hypersensitivity to E. coli Asparaginase in Young Adults with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Jazz Pharmaceuticals, Inc.0 个研究点目标入组 30 人开始时间: 2014年12月8日最近更新: 2015年7月10日

试验速览

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•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

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