Spots Global Cancer Trial Database for A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
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Trial Identification
Brief Title: A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
Official Title: A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
Study ID: NCT02257684
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).
Detailed Description: The purpose of the study was to assess the response rate in children and young adults with ALL/LBL and hypersensitivity to pegaspargase defined as the proportion of subjects having a serum asparaginase activity (SAA) level of ≥ 0.1 IU/mL 14 days following the first IV pegcrisantaspase dose in Course 1. Also, to assess the safety of IV pegcrisantaspase therapy in children and young adults with ALL/LBL with hypersensitivity to pegaspargase.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Miller Children's Hospital, Long Beach, California, United States
Children's Hospital of Los Angeles, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Kaiser Permanente, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Benioff Children's Hospital / UCSF Benioff Children's Hospital, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center Center for Cancer & Blood Disorders, Washington, District of Columbia, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Riley Hospital for Children / Indiana University, Indianapolis, Indiana, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Children's Hospital Main Campus, New Orleans, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
C.S. Mott / University of Michigan, Ann Arbor, Michigan, United States
Wayne State University c/o Children's Hospital of Michigan, Detroit, Michigan, United States
University of Minnesota Medical Center - Fairview, Minneaplois, Minnesota, United States
Children's Hospitals & Clinics of Minnesota, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital - Kansas City, Kansas City, Missouri, United States
Washington University School of Medicine, St. Louis, Missouri, United States
Children's Hospital & Medical Center of Omaha, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Carolinas Medical Center, Levine Cancer Institute, Levine Children's Hospital, Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center, Oklahoma, Oklahoma, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Bi-Lo Charities Children's Cancer Center, Greenville, South Carolina, United States
Vanderbilt University Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center, Austin, Texas, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Hospital / Baylor College of Medicine, Houston, Texas, United States
Seattle Children's Hospital, Seatlle, Washington, United States
University of Wisconsin / American Family Children's Hospital, Madison, Wisconsin, United States
Children's Hospital of Wisconsin / Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Roman Skowronski, MD, PhD
Affiliation: Jazz Pharmaceuticals
Role: STUDY_DIRECTOR
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