At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
asparaginase Erwinia chrysanthemidrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
In Brief
A Phase 2 clinical trial evaluating asparaginase Erwinia chrysanthemi for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Completed, enrolled 30 participants across 22 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartNov 2012
Primary CompletionAug 2013
Study CompletionDec 2013
TodayJul 2026
First PostedJul 18, 2012
Enrollment StartNov 1, 2012
Primary CompletionAug 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.0 years ago
Interventions
asparaginase Erwinia chrysanthemidrug