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Brief Title: An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
Official Title: An Open-Label, Multicenter Study of Recombinant Crisantaspase Produced in Pseudomonas Fluorescens (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. Coli-derived Asparaginases
Study ID: NCT04145531
Brief Summary: This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Children's of Alabama, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Kaiser Permanente - Orange County - Anaheim Medical Center, Anaheim, California, United States
Kaiser Permanente - Downey Medical Center, Downey, California, United States
Kaiser Permanente - Fontana Medical Center, Fontana, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
MemorialCare Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Kaiser Permanente- Los Angeles Medical Center, Los Angeles, California, United States
Benioff Children's Hospital Oakland, Oakland, California, United States
Kaiser Permanente - Oakland Medical Center, Oakland, California, United States
Children's Hospital of Orange County Main Campus - Orange, Orange, California, United States
Kaiser Permanente - Roseville Medical Center, Roseville, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Kaiser Permanente - San Diego Medical Center, San Diego, California, United States
University of California San Francisco Benioff Children's Hospital - Mission Bay, San Francisco, California, United States
Kaiser Permanente - Santa Clara Medical Center, Santa Clara, California, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Smilow Cancer Hospital - New Haven, New Haven, Connecticut, United States
Nemours Alfred I. Dupont Hospital for Children, Wilmington, Delaware, United States
Children's National Health System, Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Memorial Medical Office Centre, Hollywood, Florida, United States
Nemours Children's Specialty Care Jacksonville, Jacksonville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Scottish Rite Hospital, Atlanta, Georgia, United States
Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States
Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Norton Children's Hospital, Louisville, Kentucky, United States
Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Minnesota, Minneapolis, Minnesota, United States
Masonic Cancer Center, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, United States
Alliance for Childhood Diseases, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Cohen Children's Medical Center, New Hyde Park, New York, United States
NYU - Stephen D. Hassenfeld Children's Center for Cancer and Blood Disorders, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center - New York, New York, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The Children's Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Neurology Clinic, P.C, Cordova, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Children's Blood and Cancer Center, Austin, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Methodist Hospital - San Antonio, San Antonio, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Inova Medical Group - Fairfax Hospital, Falls Church, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center, Spokane, Washington, United States
CancerCare Manitoba - McDermot and Urgent Care Site, Winnipeg, Manitoba, Canada
McMaster Children's Hospital, Hamilton, Ontario, Canada
Victoria Hospital & Children's Hospital, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
SickKids - The Hospital for Sick Children, Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montréal, Quebec, Canada
The Montreal Children's Hospital, Montréal, Quebec, Canada