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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EUSA Pharma (US), Inc.
ClinicalTrials.gov Identifier:
NCT01643408
First received: June 25, 2012
Last updated: May 8, 2014
Last verified: May 2014

June 25, 2012
May 8, 2014
November 2012
August 2013   (final data collection date for primary outcome measure)
2 day NSAA level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To determine the proportion of patients with 2 day nadir serum asparaginase activity (NSAA) levels (48 hour levels taken after the 5th dose) that are > or = to 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
2 day NSAA level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
T determine the proportionof patients with 2 day nadir serum asparaginase activity (NSAA) levels (48 hour levels taken after teh 5th dose) that are > or = to 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
Complete list of historical versions of study NCT01643408 on ClinicalTrials.gov Archive Site
  • 3 day NSAA level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of patients with 3 day NSAA level (72 hour levels taken after the 6th dose)that are > or = to 01 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose
  • Asparaginase related toxicities [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    To describe the frequency of asparaginase related toxicities within the first 3 or 4 weeks of treatment associated with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma who have developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol.
  • NSAA over time [ Time Frame: 4 - 30 weeks ] [ Designated as safety issue: No ]
    To describe the NSAA over time in patients 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).
  • Frequency of asparaginase related toxicities in patients with longer duration of Erwinaze use. [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    To describe the frequency of asparaginase related toxicities associated with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma and who have developed hypersensitivity to Native E. coli asparaginase, Pegaspargase or Calaspargase pegol with longer duration of Erwinaze use (4 - 30 weeks).
  • 3 day NSAA level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of patients with 3 day NSAA level (72 hour levels taken after the 6th dose)that are > or = to 01 IU/mL in the first 2 weeks of treatmetn with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose
  • Asparaginase related toxicities [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    To describe the frequency of asparaginase related toxicities within thef irst 3 or 4 weeks of treatment assocaited with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma who have developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol.
  • NSAA over time [ Time Frame: 4 - 30 weeks ] [ Designated as safety issue: No ]
    To describe the NSAA over time in patients 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).
  • Frequency of asparaginase related toxicities in patients with longer duration of Erwinaze use. [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    To describe the frequency of asparaginase related toxicities assocaited with intravenous Erwinaze treatment in patients with ALL/Lymphoblastic Lymphoma and who have developed hypersensitivity to Native E. coli asparaginase, Pegaspargase or Calaspargase pegol with longer duration of Erwinaze use (4 - 30 weeks).
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
Drug: asparaginase Erwinia chrysanthemi
No Intervention: Treatment
Route of administration
Intervention: Drug: asparaginase Erwinia chrysanthemi
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2013
August 2013   (final data collection date for primary outcome measure)

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 byt he patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.

Exclusion Criteria:

-

Both
1 Year to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01643408
100EUSA12
Yes
EUSA Pharma (US), Inc.
EUSA Pharma (US), Inc.
Not Provided
Principal Investigator: Lynda Vrooman, MD Dana-Farber Cancer Institute
EUSA Pharma (US), Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP