A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
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.
1 other identifier
interventional
30
2 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2012
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
June 23, 2021
CompletedJune 23, 2021
June 1, 2021
9 months
June 25, 2012
April 28, 2021
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
48 hours post-dose 5
Three Day NSAA Level
72 hours post-dose 6
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
72 hours post-dose 6
Nadir Serum Asparaginase Activity Over Time
4 weeks to 30 weeks
Study Arms (1)
Open-Label Erwinaze
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Orange County
Orange County, California, 92868, United States
Stanford Medical Center
Palo Alto, California, 94304, United States
Children's Hospital
Aurora, Colorado, 80045, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Memorial Hospital
Chicago, Illinois, 60611, United States
John Hopkins
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Michigan, 55455, United States
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, 55406, United States
UMDNJ/Robert Wood Johnson
New Brunswick, New Jersey, 08903, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Montifiore Medical Center
The Bronx, New York, 10467, United States
Oregon Health & Sciences
Portland, Oregon, 97239, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Inova Fairfax Medical Center
Falls Church, Virginia, 22042, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
McMasters University Medical Center
Hamilton, Ontario, L8S4R1, Canada
Sick Children's Hospital
Toronto, Ontario, m561X8, Canada
Hospital St. Justine
Saint Catherine, Quebec, H3T1CS, Canada
Quebec Children's Hospital
Sainte-Foy, Quebec, CIV462, Canada
Related Publications (1)
Vrooman LM, Kirov II, Dreyer ZE, Kelly M, Hijiya N, Brown P, Drachtman RA, Messinger YH, Ritchey AK, Hale GA, Maloney K, Lu Y, Plourde PV, Silverman LB. Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2016 Feb;63(2):228-33. doi: 10.1002/pbc.25757. Epub 2015 Sep 16.
PMID: 26376459DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Disclosure & Transparency
- Organization
- Jazz Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Lynda Vrooman, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2012
First Posted
July 18, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
June 23, 2021
Results First Posted
June 23, 2021
Record last verified: 2021-06