A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Non-Hodgkin Lymphoma, Pediatric Leukemia
NCT ID: NCT01643408
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-419
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Lynda Vrooman, MD,
Dana Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
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 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:
-