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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145531
Other study ID # JZP458-201
Secondary ID AALL1931
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date December 27, 2019
Est. completion date July 13, 2022

Study information

Verified date November 2023
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date July 13, 2022
Est. primary completion date July 13, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Pediatric and adult patients with a diagnosis of ALL or LBL. 2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation. 3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan. 4. Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase. Exclusion Criteria: 1. Have previously received asparaginase Erwinia chrysanthemi or JZP-458. 2. Have relapsed ALL or LBL. 3. Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458. 4. Have a history of = Grade 3 pancreatitis. 5. Prior history of asparaginase-associated = Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IM JZP-458
IM JZP-458 will be administered in Part A, Cohorts 1 & 2
IV JZP-458
IV JZP-458 will be administered in Part B

Locations

Country Name City State
Canada McMaster Children's Hospital Hamilton Ontario
Canada Victoria Hospital & Children's Hospital London Ontario
Canada Centre Hospitalier Universitaire Sainte-Justine Montréal Quebec
Canada The Montreal Children's Hospital Montréal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada SickKids - The Hospital for Sick Children Toronto Ontario
Canada CancerCare Manitoba - McDermot and Urgent Care Site Winnipeg Manitoba
United States Kaiser Permanente - Orange County - Anaheim Medical Center Anaheim California
United States C.S. Mott Children's Hospital Ann Arbor Michigan
United States Scottish Rite Hospital Atlanta Georgia
United States Children's Blood and Cancer Center Austin Texas
United States Children's of Alabama Birmingham Alabama
United States Dana-Farber/Boston Children's Cancer and Blood Disorders Center Boston Massachusetts
United States Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Neurology Clinic, P.C Cordova Tennessee
United States Medical City Dallas Hospital Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Kaiser Permanente - Downey Medical Center Downey California
United States Inova Medical Group - Fairfax Hospital Falls Church Virginia
United States Kaiser Permanente - Fontana Medical Center Fontana California
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Memorial Medical Office Centre Hollywood Florida
United States Kapi'olani Medical Center for Women and Children Honolulu Hawaii
United States Texas Children's Hospital Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Specialty Care Jacksonville Jacksonville Florida
United States East Tennessee Children's Hospital Knoxville Tennessee
United States Alliance for Childhood Diseases Las Vegas Nevada
United States Arkansas Children's Hospital Little Rock Arkansas
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 Norton Children's Hospital Louisville Kentucky
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Children's Minnesota Minneapolis Minnesota
United States Masonic Cancer Center Minneapolis Minnesota
United States Morristown Medical Center Morristown New Jersey
United States Vanderbilt University Medical Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Smilow Cancer Hospital - New Haven New Haven Connecticut
United States Cohen Children's Medical Center New Hyde Park 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 NYU - Stephen D. Hassenfeld Children's Center for Cancer and Blood Disorders New York New York
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Benioff Children's Hospital Oakland Oakland California
United States Kaiser Permanente - Oakland Medical Center Oakland California
United States The Children's Hospital at Oklahoma University Medical Center Oklahoma City Oklahoma
United States Children's Hospital of Orange County Main Campus - Orange Orange California
United States AdventHealth Orlando Orlando Florida
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Massey Cancer Center Richmond Virginia
United States Kaiser Permanente - Roseville Medical Center Roseville California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Washington University School of Medicine in Saint Louis Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Primary Children's Hospital Salt Lake City Utah
United States Methodist Hospital - San Antonio San Antonio Texas
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 Seattle Children's Hospital Seattle Washington
United States Providence Sacred Heart Medical Center Spokane Washington
United States Children's National Health System Washington District of Columbia
United States Nemours Alfred I. Dupont Hospital for Children Wilmington Delaware
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Jazz Pharmaceuticals Children's Oncology Group (COG)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Maese L, Loh ML, Choi MR, Lin T, Aoki E, Zanette M, Agarwal S, Iannone R, Silverman JA, Silverman LB, Raetz EA, Rau RE. Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study. Blood. 2023 Feb 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate During the First Course of JZP-458 Administration The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level = 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination. Baseline up to 2 weeks
Primary Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months
Secondary Number of Participants With Last 48-hour NSAA Level = 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration Blood samples were collected for serum asparaginase activity level determination. Baseline up to 2 weeks
Secondary Number of Participants With Last NSAA Levels = 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration Blood samples were collected for serum asparaginase activity level determination. Baseline up to 2 weeks
Secondary Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported. Up to 2 weeks (6 doses)
Secondary Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458 Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test. Baseline up to 30 days (ADA- samples) after last dose of last course and up to 6 months (ADA+ samples) after last dose of last course, up to approximately 2 years 7 months
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