A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643408
• Other study ID #: 100EUSA12
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2021
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• asparaginase Erwinia chrysanthemi

Locations

Country	Name	City	State
Canada	McMasters University Medical Center	Hamilton	Ontario
Canada	Hospital St. Justine	Saint Catherine	Quebec
Canada	Quebec Children's Hospital	Sainte-Foy	Quebec
Canada	Sick Children's Hospital	Toronto	Ontario
United States	Children's Hospital	Aurora	Colorado
United States	John Hopkins	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Montifiore Medical Center	Bronx	New York
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Inova Fairfax Medical Center	Falls Church	Virginia
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospital and Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Michigan
United States	UMDNJ/Robert Wood Johnson	New Brunswick	New Jersey
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Children's Hospital of Orange County	Orange County	California
United States	Stanford Medical Center	Palo Alto	California
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences	Portland	Oregon
United States	All Children's Hospital	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two Day Nadir Serum Asparaginase Activity (NSAA) Level	To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.	48 hours post-dose 5
Secondary	Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours	To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.	48 hours post-dose 5
Secondary	Three Day NSAA Level	To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.	72 hours post-dose 6
Secondary	Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours	To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.	72 hours post-dose 6
Secondary	Nadir Serum Asparaginase Activity Over Time	To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).	4 weeks to 30 weeks