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

Primary Purpose

Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
asparaginase Erwinia chrysanthemi
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Erwinaze, asparaginase, Eusa Pharma, Pharmacokinetic study, NSAA

Eligibility Criteria

1 Year - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Children's Hospital of Los Angeles
  • Children's Hospital of Orange County
  • Stanford Medical Center
  • Children's Hospital
  • All Children's Hospital
  • Children's Memorial Hospital
  • John Hopkins
  • Dana Farber Cancer Institute
  • University of Minnesota
  • Children's Hospital and Clinics of Minnesota
  • UMDNJ/Robert Wood Johnson
  • Montifiore Medical Center
  • Columbia Presbyterian Medical Center
  • Oregon Health & Sciences
  • Children's Hospital of Pittsburgh
  • Texas Children's Hospital
  • Inova Fairfax Medical Center
  • Children's Hospital of Wisconsin
  • McMasters University Medical Center
  • Sick Children's Hospital
  • Hospital St. Justine
  • Quebec Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Erwinaze

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
June 25, 2012
Last Updated
June 1, 2021
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01643408
Brief Title
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Keywords
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Erwinaze, asparaginase, Eusa Pharma, Pharmacokinetic study, NSAA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Erwinaze
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
asparaginase Erwinia chrysanthemi
Primary Outcome Measure Information:
Title
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
Description
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.
Time Frame
48 hours post-dose 5
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
Description
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.
Time Frame
48 hours post-dose 5
Title
Three Day NSAA Level
Description
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.
Time Frame
72 hours post-dose 6
Title
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
Description
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.
Time Frame
72 hours post-dose 6
Title
Nadir Serum Asparaginase Activity Over Time
Description
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).
Time Frame
4 weeks to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Vrooman, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange County
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Michigan
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Hospital and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55406
Country
United States
Facility Name
UMDNJ/Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Montifiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health & Sciences
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Fairfax Medical Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
McMasters University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4R1
Country
Canada
Facility Name
Sick Children's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
m561X8
Country
Canada
Facility Name
Hospital St. Justine
City
Saint Catherine
State/Province
Quebec
ZIP/Postal Code
H3T1CS
Country
Canada
Facility Name
Quebec Children's Hospital
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
CIV462
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26376459
Citation
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.
Results Reference
derived

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

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