Clinical trialNCT01643408CompletedPhase 2Interventional

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

SponsorJazz PharmaceuticalsEnrollment30Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Lynda Vrooman, MD
Dana-Farber Cancer Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

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

United States

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
St. 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
Columbia Presbyterian Medical Center
New York, New York, United States
Montifiore Medical Center
The Bronx, 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Asparaginase →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2012
Primary completion: 31 Aug 2013
Completion: 31 Dec 2013
Last update posted: 23 Jun 2021
Registered enrollment: 30
Registry id: NCT01643408

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.