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

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
• Interventions: Drug: asparaginase Erwinia chrysanthemi

• Registration Number: NCT01643408
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Study Start: 2012-11
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Results First Submitted: 2021-04-28
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Results First Posted: 2021-06-23
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (22)

John Hopkins; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Hospital St. Justine; 🇨🇦 Saint Catherine, Quebec, Canada

Children's Hospital of Orange County; 🇺🇸 Orange County, California, United States

Children's Hospital and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Stanford Medical Center; 🇺🇸 Palo Alto, California, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

UMDNJ/Robert Wood Johnson; 🇺🇸 New Brunswick, New Jersey, United States

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Montifiore Medical Center; 🇺🇸 Bronx, New York, United States

Oregon Health & Sciences; 🇺🇸 Portland, Oregon, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Michigan, United States

Inova Fairfax Medical Center; 🇺🇸 Falls Church, Virginia, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Sick Children's Hospital; 🇨🇦 Toronto, Ontario, Canada

Quebec Children's Hospital; 🇨🇦 Sainte-Foy, Quebec, Canada

McMasters University Medical Center; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital; 🇺🇸 Aurora, Colorado, United States