Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
St. Jude Children's Research Hospital
With
Jazz Pharmaceuticals
Parexel
Primary Objective
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 and/or PEG-asparaginase.
TREATMENT PLAN
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Documented history of severe hypersensitivity or intolerance to Erwinase
Clareo Health | Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
