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

Phase 2

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Open-Label Erwinaze	asparaginase Erwinia chrysanthemi	-

Primary Outcome Measures

Name	Time	Method
Two Day Nadir Serum Asparaginase Activity (NSAA) Level	48 hours post-dose 5	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.

Secondary Outcome Measures

Name	Time	Method
Nadir Serum Asparaginase Activity Over Time	4 weeks to 30 weeks	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).
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours	48 hours post-dose 5	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.
Three Day NSAA Level	72 hours post-dose 6	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.
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours	72 hours post-dose 6	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.

Locations (22): Children's Hospital of Los Angeles
🇺🇸
Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸
Orange County, California, United States
Stanford Medical Center
🇺🇸
Palo Alto, California, United States
Children's Hospital
🇺🇸
Aurora, Colorado, United States
All Children's Hospital
🇺🇸
Saint Petersburg, Florida, United States
Children's Memorial Hospital
🇺🇸
Chicago, Illinois, United States
John Hopkins
🇺🇸
Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
University of Minnesota
🇺🇸
Minneapolis, Michigan, United States
Children's Hospital and Clinics of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
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Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States