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NCT04145531 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
NCT04145531: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT04145531 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 229 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04145531, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG IM JZP-458
- DRUG IV JZP-458
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2022-07-13 |
| Phase | Phase 2 |
What the finished NCT04145531 record still lists
NCT04145531 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 2 interventions - of which IM JZP-458 is the first listed.
NCT04145531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04145531 about?
NCT04145531 is a clinical study titled "An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)". 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 ...
What is the current status of trial NCT04145531?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2019-12-27. Estimated completion is 2022-07-13.
What interventions are being tested in trial NCT04145531?
The interventions under investigation include: IM JZP-458 (DRUG), IV JZP-458 (DRUG).
Who is sponsoring clinical trial NCT04145531?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04145531's enrollment target sits among peer trials
229 264th of 2000 higher than 1,737 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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