Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)
6 other identifiers
interventional
59
1 country
43
Brief Summary
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedStudy Start
First participant enrolled
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedResults Posted
Study results publicly available
August 22, 2014
CompletedJuly 9, 2019
June 1, 2019
3 years
September 27, 2007
October 7, 2013
June 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL
Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase
48 hours post administration of Erwinia asparaginase
Secondary Outcomes (3)
Determine if Plasma Asparagine is Adequately Depleted
On days 12 or 13
Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase
At baseline, prior to doses 4, 5, and 6 and on days 15 and 22
Percentage of Participants Who Experienced Toxicities
up to 1 year
Study Arms (1)
Treatment (chemotherapy)
EXPERIMENTALPatients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Interventions
Given IM
Eligibility Criteria
You may qualify if:
- Diagnosis of acute lymphoblastic leukemia
- Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
- Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
- Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
- No history of pancreatitis ? grade 2
- No prior Erwinia asparaginase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (43)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Central California
Madera, California, 93636-8762, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
Harbor-University of California at Los Angeles Medical Center
Torrance, California, 90502, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Wanda Salzer
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
February 11, 2008
Primary Completion
February 1, 2011
Last Updated
July 9, 2019
Results First Posted
August 22, 2014
Record last verified: 2019-06