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Completed

NCT Number: NCT04145531

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Leukemia Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CancerCare Manitoba - McDermot and Urgent Care Site, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IM JZP-458

Drug

IM JZP-458 will be administered in Part A, Cohorts 1 & 2

IV JZP-458

Drug

IV JZP-458 will be administered in Part B

Primary outcomes

  1. Response Rate During the First Course of JZP-458 Administration

    Time frame: Baseline up to 2 weeks

    The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.

  2. Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

    Time frame: Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months

    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Secondary outcomes

  1. Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration

    Time frame: Baseline up to 2 weeks

    Blood samples were collected for serum asparaginase activity level determination.

  2. Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration

    Time frame: Baseline up to 2 weeks

    Blood samples were collected for serum asparaginase activity level determination.

  3. Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration

    Time frame: Up to 2 weeks (6 doses)

    Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported.

  4. Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458

    Time frame: Baseline up to 30 days (ADA- samples) after last dose of last course and up to 6 months (ADA+ samples) after last dose of last course, up to approximately 2 years 7 months

    Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Collaborators

  • Children's Oncology Group

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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