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

NCT02150928 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-05-13

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bengt Bergstrom, Md, PhD · Jazz Pharamceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-06-30

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150928 on ClinicalTrials.gov