Phase 2
Completed N=30
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Source: ClinicalTrials.gov NCT01643408 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jun 2021
Primary outcomePrimary: Two Day Nadir Serum Asparaginase Activity (NSAA) Level — 0.32 (IU/mL)
Summary
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two Day Nadir Serum Asparaginase Activity (NSAA) Level |
0.32 | — |
| SECONDARY Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours |
20 | — |
| SECONDARY Three Day NSAA Level |
0.09 | — |
| SECONDARY Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours |
9 | — |
| SECONDARY Nadir Serum Asparaginase Activity Over Time |
0.51 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
- Ages >/= 1 and </= to 30 years at the time of initial diagnosis
- Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
- Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
- Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
- Direct bilirubin less than or equal to Grade 2
- Amylase and lipase within normal limits (per institutional standards)
- Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01643408). 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.