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: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Drug: asparaginase Erwinia chrysanthemi
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by EUSA Pharma (US), Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 30
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment
Route of administration
Drug: asparaginase Erwinia chrysanthemi

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643408

  Show 22 Study Locations
Sponsors and Collaborators
EUSA Pharma (US), Inc.
Investigators
Principal Investigator: Lynda Vrooman, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: EUSA Pharma (US), Inc.
ClinicalTrials.gov Identifier: NCT01643408     History of Changes
Other Study ID Numbers: 100EUSA12
Study First Received: June 25, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EUSA Pharma (US), Inc.:
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Erwinaze
asparaginase
Eusa Pharma
Pharmacokinetic study
NSAA

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014