An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) Administered Following Hypersensitivity to E. Coli Asparaginase in Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.

Study Overview

• Status: Withdrawn
• Conditions: Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
• Intervention / Treatment: Drug: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have a diagnosis of ALL or LBL
2. Be 18 to <40 years of age at the time of enrollment
3. Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)

4. Have the following asparaginase doses remaining in their treatment plan:

   • At least two (2) consecutive weeks of native E. coli asparaginase treatment OR
   • At least one (1) dose of pegaspargase (Oncaspar)
5. Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])
6. Have amylase and lipase within normal limits (per institutional standards)
7. Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze)
8. Consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months prior to baseline), and progestin implant or injection.
9. Have signed informed consent

Exclusion Criteria:

1. Prior history of ≥ Grade 3 pancreatitis
2. Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
3. Prior treatment with Erwinaze
4. Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
5. Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
6. Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Erwinaze / Erwinase

Drug: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase); Enrolled patients will receive asparaginase Erwinia chrysanthemi 25,000 IU/m2 administered intramuscularly (IM) on a Monday/Wednesday/Friday schedule (all dosing regimens will start on a Monday); All patients will receive at least 1 course (2 weeks) of treatment with asparaginase Erwinia chrysanthemi (1 course=6 doses), and a maximum number of courses needed to complete their remaining asparaginase therapy (up to 15 courses); Eligible patients may not begin treatment with asparaginase Erwinia chrysanthemi until their serum asparaginase activity level is below the assay detectable limit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum asparaginase activity levels	48 h postdose 5

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals
• Investigators: Study Director: Bengt Bergstrom, Md, PhD, Jazz Pharamceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Antineoplastic Agents; Asparaginase
• Other Study ID Numbers: 13-006