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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2015

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"

Trial Locations (1)

31008

Hospital of Navarra, Pamplona

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY