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

This study is currently recruiting participants.

Verified May 2013 by EUSA Pharma (US), Inc.

Sponsor:

Information provided by (Responsible Party):

EUSA Pharma (US), Inc.

ClinicalTrials.gov Identifier:

NCT01643408

First received: June 25, 2012

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2012

Last Updated Date

May 2, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01643408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

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).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma

Intervention ^ICMJE

Drug: asparaginase Erwinia chrysanthemi

Study Arm (s)

No Intervention: Treatment

Route of administration

Intervention: Drug: asparaginase Erwinia chrysanthemi

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

1 Year to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Colleen Gramkowski	215-867-4919	colleen.gramkowski@jazzpharma.com
Contact: Roxanne MacDonald	215-867-4993	roxanne.macdonald@jazzpharma.com

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT01643408

Other Study ID Numbers ^ICMJE

100EUSA12

Has Data Monitoring Committee

Yes

Responsible Party

EUSA Pharma (US), Inc.

Study Sponsor ^ICMJE

EUSA Pharma (US), Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lynda Vrooman, MD

Dana-Farber Cancer Institute

Information Provided By

EUSA Pharma (US), Inc.

Verification Date

May 2013

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

To Top