NCT02150928

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• First posted: 2014-05-30
• Last updated: 2015-05-13

Locations

1 site across 1 country: Spain