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Erwinase Master Treatment Protocol


N/A
N/A
N/A
Not Enrolling
Both
Leukemia, Acute Lymphoblastic, Acute Lymphoid Leukemia

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Trial Information

Erwinase Master Treatment Protocol


Inclusion Criteria:



- Patient must give written informed consent to receive Erwinase.

- Patient must be treated for acute lymphoblastic leukemia.

- Patient must have either systemic hypersensitivity reactions to native (Elspar) or
pegylated E.coli asparaginase (Oncaspar). This includes patients with generalized
rash with or without anaphylactic symptoms, or patients with previously documented
local or systemic reactions to E.coli derived L-asparaginase.

Exclusion Criteria:

- Previous allergic reaction to Erwinia L-asparaginase (Erwinase)

- Previous acute pancreatitis

- Pregnant or lactating woman

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

Erwinase

NCT ID:

NCT00590915

Start Date:

Completion Date:

Related Keywords:

  • Leukemia, Acute Lymphoblastic
  • Acute Lymphoid Leukemia
  • ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Acute Disease

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