An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
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ClinicalTrials.gov Identifier: NCT04145531 |
Recruitment Status :
Recruiting
First Posted : October 30, 2019
Last Update Posted : April 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia Lymphoblastic Leukemia | Drug: IM JZP-458 Drug: IV JZP-458 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 135 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 27, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: JZP-458
Part A (IM JZP-458) of the study will have 2 IM cohorts:
Part B (IV JZP-458 Dose Confirmation) will be conducted to define the optimal dose of the IV administration of JZP-458 for further study in ALL/LBL patients as a repeated dose. Additional courses of JZP-458 (IM or IV depending on patient's allocation at study enrollment) will be administered based on each patient's original treatment plan for as long as the patient derives clinical benefit. |
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 |
- Response Rate During the First Course of IM JZP-458 [ Time Frame: 2 weeks ]The response rate is defined as the proportion of patients with the last 72-hour NSAA level ≥ 0.1 IU/mL during the first course of IM JZP-458.
- Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]
- Proportion of patients with the last 48-hour NSAA level ≥ 0.1 IU/mL during the first course of IM administration of JZP-458 [ Time Frame: 2 weeks ]For patients in Part A
- Proportion of patients with the last 48-hour NSAA level ≥ 0.4 IU/mL during the first course of IM administration of JZP-458 [ Time Frame: 2 weeks ]For patients in Part A
- Proportion of patients with the last 72-hour NSAA level ≥ 0.4 IU/mL during the first course of IM administration of JZP-458 [ Time Frame: 2 weeks ]For patients in Part A
- JZP-458 Pharmacokinetics [ Time Frame: Up to 30 days after last dose ]For patients in Part A. Serum asparaginase activity levels after Course 1 (6 doses), then after each subsequent Courses during a patient's treatment plan.
- Incidence of anti-drug antibody formation against JZP-458 [ Time Frame: Up to 30 days after last dose ]For patients in Part A

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145531
Contact: Director Clinical Trial Disclosure & Transparency | 2159707145 | ClinicalTrialDisclosure@JazzPharma.com |

Responsible Party: | Jazz Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04145531 |
Other Study ID Numbers: |
JZP458-201 AALL1931 ( Other Identifier: Children's Oncology Group ) |
First Posted: | October 30, 2019 Key Record Dates |
Last Update Posted: | April 9, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ALL LBL Asparaginase Leukemia Childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |