Clinical Trials /

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

NCT04145531

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
IM JZP-458JZP-458
IV JZP-458JZP-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

NameTypeDescriptionInterventions
JZP-458ExperimentalPart 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.
  • IM JZP-458
  • IV JZP-458

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

December 10, 2019