Clinical trial
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic…
NCT04145531 · Jazz Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT04145531 |
|---|---|
| Title | An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) |
| Official title | 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 |
| Lead sponsor | Jazz Pharmaceuticals, Industry |
| Collaborators | Children's Oncology Group |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia |
| Intervention type | Drug |
| Interventions | IM JZP-458, IV JZP-458 |
| Enrollment | 229 |
| Start date | Dec 27, 2019 |
| Primary completion | Jul 13, 2022 |
| Completion | Jul 13, 2022 |
| First posted | Oct 30, 2019 |
| Last update posted | Nov 18, 2023 |
| Countries | Canada, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: