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.
1 Year
30 Years
Both
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Trial Information
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.
Inclusion Criteria:
- Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
- Ages >/= 1 and
- 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 byt he patient is greater than or equal to 18 years or by the
parent if the patient is younger than 18 years old.
Exclusion Criteria:
-
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
2 day NSAA level
Outcome Description:
To determine the proportion of patients with 2 day nadir serum asparaginase activity (NSAA) levels (48 hour levels taken after the 5th dose) that are > or = to 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:
4 weeks
Safety Issue:
No
Principal Investigator
Lynda Vrooman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
100EUSA12
NCT ID:
NCT01643408
Start Date:
July 2012
Completion Date:
December 2013
Related Keywords:
- Acute Lymphoblastic Leukemia
- Lymphoblastic Lymphoma
- Acute Lymphoblastic Leukemia
- Lymphoblastic Lymphoma
- Erwinaze
- asparaginase
- Eusa Pharma
- Pharmacokinetic study
- NSAA
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53201 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Columbia Presbyterian Medical Center | New York, New York 10032 |
| Texas Children's Hospital | Houston, Texas |
| Children's Hospital | Denver, Colorado 80218 |
| Children's Memorial Hospital | Chicago, Illinois 60614 |
| Stanford Medical Center | Stanford, California 94303 |
| Children's Hospital of Los Angeles | Los Angeles, California 90027 |
| John Hopkins | Baltimore, Maryland 21205 |
| Children's Hospital and Clinics of Minnesota | Minneapolis, Minnesota 55404 |
| University of Minnesota | Minneapolis, Michigan 55455 |
| UMDNJ/Robert Wood Johnson | New Brunswick, New Jersey 08903 |
| Montifiore Medical Center | Bronx, New York 10467 |
| Oregon Health & Sciences | Portland, Oregon 97239 |
| Inova Fairfax Medical Center | Falls Church, Virginia 22042 |
