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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
229
IM JZP-458 will be administered in Part A, Cohorts 1 \& 2
IV JZP-458 will be administered in Part B
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.
Time frame: Baseline up to 2 weeks
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.
Time frame: Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months
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.
Time frame: Baseline up to 2 weeks
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.
Time frame: Baseline up to 2 weeks
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.
Time frame: Up to 2 weeks (6 doses)
Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 64 more locations
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.
Time frame: 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