Clinical trial · Interventional
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
NCT00506597CI-TRIAL-00015587completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erwinase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erwinase
- description
- 6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
- interventionNames
- Drug: Erwinase
Primary outcomes (2)
- measure
- Participant Toxicity Data
- timeFrame
- 3 Years
- description
- Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
- measure
- 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
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Age: no restrictions 2. Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290. 3. Patient must be treated for Acute Lymphoblastic Leukemia 4. Patient with either T or B cell lymphoma being treated with Asparaginase. 5. 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. 6. Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase. 7. Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available. Exclusion Criteria: 1. Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®) 2. Previous acute pancreatitis 3. Pregnant or lactating woman
References
Publications (0)
Data not yet available
No reference posted for this study.