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
  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: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 8, 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 July 20, 2014