This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL)
who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or
To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins
lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase
Erwinia L-asparaginase administration will be given according to the protocol or
non-protocol treatment plan under which the patient is currently being treated.
Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade
3 or higher adverse event believed to be attributable to this agent.
- Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma
receiving ALL-type therapy who have developed hypersensitivity or intolerance to E.
coli L-asparaginase or PEG-L-asparaginase or both.
- Informed consent explained to and signed by parent/legal guardian, with emphasis that
although approved for use in Europe and Canada, Erwinase is NOT approved by the
United States Food and Drug Administration
- Documented history of severe hypersensitivity or intolerance to Erwinase