Clinical trial NCT04145531
Conditions: Acute Lymphoblastic Leukemia Lymphoblastic Leukemia
Keywords: ALL LBL Asparaginase Leukemia Childhood acute lymphoblastic leukemia
Sponsor: Jazz Pharmaceuticals
Start date: 2019-12-27; Completion date: 2022-07-13
Enrollment: 229 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief 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.

Detailed description:

Arms: arm 1: 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.
Interventions: intervention 1: IM JZP-458 intervention 2: IV JZP-458
Intervention descriptions: intervention 1: IM JZP-458 will be administered in Part A, Cohorts 1 \& 2 intervention 2: IV JZP-458 will be administered in Part B

Protocol documents:
SAP_002.pdf: 
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03 Sep 2020
CONFIDENTIAL
Page 16 of 92
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03 Sep 2020
CONFIDENTIAL
Page 17 of 92
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03 Sep 2020
CONFIDENTIAL
Page 18 of 92
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03 Sep 2020
CONFIDENTIAL
Page 19 of 92
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03 Sep 2020
CONFIDENTIAL
Page 20 of 92
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Page 82 of 92
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