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

Primary Purpose

Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Status

Withdrawn

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of ALL or LBL
Be 18 to <40 years of age at the time of enrollment
Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
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)
Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])
Have amylase and lipase within normal limits (per institutional standards)
Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze)
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.
Have signed informed consent

Exclusion Criteria:

Prior history of ≥ Grade 3 pancreatitis
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
Prior treatment with Erwinaze
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
Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial

Sites / Locations

Hospital of Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erwinaze / Erwinase

Arm Description

Outcomes

Primary Outcome Measures

Serum asparaginase activity levels

Secondary Outcome Measures

Full Information

NCT ID

NCT02150928

First Posted

May 21, 2014

Last Updated

May 11, 2015

Sponsor

Jazz Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02150928

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Study Start Date

May 2014 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jazz Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erwinaze / Erwinase

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum asparaginase activity levels

Time Frame

48 h postdose 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of ALL or LBL Be 18 to <40 years of age at the time of enrollment Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar) 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) Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L]) Have amylase and lipase within normal limits (per institutional standards) Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze) 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. Have signed informed consent Exclusion Criteria: Prior history of ≥ Grade 3 pancreatitis 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 Prior treatment with Erwinaze 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 Subjects with a history of human immunodeficiency virus (HIV) or hepatitis. Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bengt Bergstrom, Md, PhD

Organizational Affiliation

Jazz Pharamceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Hospital of Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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