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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04145531
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Children's Oncology Group (COG)
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Lymphoblastic Leukemia Drug: IM JZP-458 Drug: IV JZP-458 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
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 : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: JZP-458

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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. Incidence of anti-drug antibody formation against JZP-458 [ Time Frame: Up to 30 days after last dose ]
    For patients in Part A


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Director Clinical Trial Disclosure & Transparency 2159707145 ClinicalTrialDisclosure@JazzPharma.com

Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
Children's Oncology Group (COG)
More Information
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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: August 4, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
ALL
LBL
Asparaginase
Leukemia
Childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases