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

June 1, 2021 updated by: Jazz Pharmaceuticals

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4R1
        • McMasters University Medical Center
      • Toronto, Ontario, Canada, m561X8
        • Sick Children's Hospital
    • Quebec
      • Saint Catherine, Quebec, Canada, H3T1CS
        • Hospital St. Justine
      • Sainte-Foy, Quebec, Canada, CIV462
        • Quebec Children's Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
      • Orange County, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Stanford Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Children's Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • John Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Minneapolis, Michigan, United States, 55455
        • University of Minnesota
    • Minnesota
      • Minneapolis, Minnesota, United States, 55406
        • Children's Hospital and Clinics of Minnesota
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ/Robert Wood Johnson
    • New York
      • Bronx, New York, United States, 10467
        • Montifiore Medical Center
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label Erwinaze
Drug: asparaginase Erwinia chrysanthemi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
Time Frame: 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.
48 hours post-dose 5

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Principal Investigator: Lynda Vrooman, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100EUSA12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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