Phase 3
N=167
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
Acute Lymphoblastic Leukemia · Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT04145531 ↗Enrolled (actual)
167
Serious AEs
66.2%
Results posted
Nov 2023
Primary outcome: Primary: Response Rate During the First Course of JZP-458 Administration — 18; 70; 44; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IM JZP-458 (Drug); IV JZP-458 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate During the First Course of JZP-458 Administration |
18; 70; 44; 20 | — |
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) |
32; 83; 49; 60 | — |
| SECONDARY Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration |
31; 82; 47; 53 | — |
| SECONDARY Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration |
16; 65; 32; 10; 1; 20 | — |
| SECONDARY Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration |
0.45; 0.88; 0.66; 0.25; 0.16; 0.33 | — |
| SECONDARY Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458 |
16; 41; 25; 34; 17; 42 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pediatric and adult patients with a diagnosis of ALL or LBL.
- Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation.
- Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan.
- Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase.
Exclusion Criteria
- Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
- Have relapsed ALL or LBL.
- 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.
- Have a history of ≥ Grade 3 pancreatitis.
- Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.
Data sourced from ClinicalTrials.gov (NCT04145531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.