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Spots Global Cancer Trial Database for A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

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We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Lynda Vrooman, MD

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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