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

NCT ID: NCT02150928

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erwinaze / Erwinase

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bengt Bergstrom, Md, PhD

Role: STUDY_DIRECTOR

Jazz Pharamceuticals

Locations

Hospital of Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

13-006

Identifier Type: -

Identifier Source: org_study_id