Description:
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.
Title
- Brief 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
Clinical Trial IDs
- ORG STUDY ID:
JZP458-201
- SECONDARY ID:
AALL1931
- NCT ID:
NCT04145531
Conditions
- Acute Lymphoblastic Leukemia
- Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
IM JZP-458 | | JZP-458 |
IV JZP-458 | | JZP-458 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
JZP-458 | Experimental | Part A (IM JZP-458) of the study will have 2 IM cohorts:
Cohort 1: a JZP-458 repeat dose/confirmatory cohort; a final IM JZP-458 dose level will be selected, and
Cohort 2: an expansion cohort to confirm the efficacy and safety of the final IM JZP-458 dose level and schedule
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. | |
Eligibility Criteria
Inclusion Criteria:
1. Pediatric and adult patients with a diagnosis of ALL or LBL.
2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have
silent inactivation.
3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment
plan.
4. Patients must have, in the opinion of the Investigator, fully recovered from their
prior allergic reaction to E. coli-derived asparaginase.
Exclusion Criteria:
1. Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
2. Have relapsed ALL or LBL.
3. 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.
4. Have a history of ≥ Grade 3 pancreatitis.
5. Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or
asparaginase-associated thrombus requiring anticoagulation therapy, excluding
catheter-related thrombotic events.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response Rate During the First Course of IM JZP-458 |
Time Frame: | 2 weeks |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | For patients in Part A |
Measure: | 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 |
Safety Issue: | |
Description: | For patients in Part A |
Measure: | 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 |
Safety Issue: | |
Description: | For patients in Part A |
Measure: | JZP-458 Pharmacokinetics |
Time Frame: | Up to 30 days after last dose |
Safety Issue: | |
Description: | 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. |
Measure: | Incidence of anti-drug antibody formation against JZP-458 |
Time Frame: | Up to 30 days after last dose |
Safety Issue: | |
Description: | For patients in Part A |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jazz Pharmaceuticals |
Trial Keywords
- ALL
- LBL
- Asparaginase
- Leukemia
- Childhood acute lymphoblastic leukemia
Last Updated
August 2, 2021