Brief Summary
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
Brief Title
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
* Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis
* Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
* Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
* Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
* Direct bilirubin less than or equal to Grade 2
* Amylase and lipase within normal limits (per institutional standards)
* Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
Exclusion Criteria:
-
* Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
* Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis
* Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
* Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
* Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
* Direct bilirubin less than or equal to Grade 2
* Amylase and lipase within normal limits (per institutional standards)
* Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
Exclusion Criteria:
-
Inclusion Criteria
Inclusion Criteria:
* Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
* Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis
* Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
* Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
* Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
* Direct bilirubin less than or equal to Grade 2
* Amylase and lipase within normal limits (per institutional standards)
* Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
* Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
* Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis
* Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
* Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
* Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
* Direct bilirubin less than or equal to Grade 2
* Amylase and lipase within normal limits (per institutional standards)
* Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
Gender
All
Gender Based
false
Keywords
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Erwinaze
asparaginase
Eusa Pharma
Pharmacokinetic study
NSAA
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
30 Years
Minimum Age
1 Year
NCT Id
NCT01643408
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
100EUSA12
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
Primary Outcomes
Outcome Description
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Outcome Measure
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
Outcome Time Frame
48 hours post-dose 5
Secondary Outcomes
Outcome Description
To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Outcome Time Frame
48 hours post-dose 5
Outcome Measure
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
Outcome Description
To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Outcome Time Frame
72 hours post-dose 6
Outcome Measure
Three Day NSAA Level
Outcome Description
To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Outcome Time Frame
72 hours post-dose 6
Outcome Measure
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
Outcome Description
To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).
Outcome Time Frame
4 weeks to 30 weeks
Outcome Measure
Nadir Serum Asparaginase Activity Over Time
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
30
Minimum Age Number (converted to Years and rounded down)
1
Investigators
Investigator Type
Principal Investigator
Investigator Name
Peter Cole
Investigator Email
pcole@montefiore.org
Investigator Phone
718-839-7462