Trials / Completed
CompletedNCT04145531
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IM JZP-458 | IM JZP-458 will be administered in Part A, Cohorts 1 \& 2 |
| DRUG | IV JZP-458 | IV JZP-458 will be administered in Part B |
Timeline
- Start date
- 2019-12-27
- Primary completion
- 2022-07-13
- Completion
- 2022-07-13
- First posted
- 2019-10-30
- Last updated
- 2023-11-18
- Results posted
- 2023-11-18
Locations
74 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04145531. Inclusion in this directory is not an endorsement.