N/A
Completed N=33
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT00506597 ↗Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Sep 2014
Primary outcomePrimary: Participant Toxicity Data
Summary
The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.
This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Toxicity Data |
— | — |
| PRIMARY Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma |
33 | — |
Eligibility Criteria
Inclusion Criteria
- Age: no restrictions
- Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
- Patient must be treated for Acute Lymphoblastic Leukemia
- Patient with either T or B cell lymphoma being treated with Asparaginase.
- Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.
- Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
- Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.
Exclusion Criteria
- Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
- Previous acute pancreatitis
- Pregnant or lactating woman
Data sourced from ClinicalTrials.gov (NCT00506597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.