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Brief Title: A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
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.
Study ID: NCT01643408
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.
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Los Angeles, Los Angeles, California, United States
Children's Hospital of Orange County, Orange County, California, United States
Stanford Medical Center, Palo Alto, California, United States
Children's Hospital, Aurora, Colorado, United States
All Children's Hospital, Saint Petersburg, Florida, United States
Children's Memorial Hospital, Chicago, Illinois, United States
John Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Michigan, United States
Children's Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States
UMDNJ/Robert Wood Johnson, New Brunswick, New Jersey, United States
Montifiore Medical Center, Bronx, New York, United States
Columbia Presbyterian Medical Center, New York, New York, United States
Oregon Health & Sciences, Portland, Oregon, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Texas Children's Hospital, Houston, Texas, United States
Inova Fairfax Medical Center, Falls Church, Virginia, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
McMasters University Medical Center, Hamilton, Ontario, Canada
Sick Children's Hospital, Toronto, Ontario, Canada
Hospital St. Justine, Saint Catherine, Quebec, Canada
Quebec Children's Hospital, Sainte-Foy, Quebec, Canada
Name: Lynda Vrooman, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR