An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
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ClinicalTrials.gov Identifier: NCT04145531 |
Recruitment Status :
Completed
First Posted : October 30, 2019
Results First Posted : November 18, 2023
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia Lymphoblastic Leukemia | Drug: IM JZP-458 Drug: IV JZP-458 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 229 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | July 13, 2022 |
Actual Study Completion Date : | July 13, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: JZP-458
Part A (IM JZP-458) of the study will have 2 IM cohorts:
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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Documents provided by Jazz Pharmaceuticals:
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 |
Results First Posted: | November 18, 2023 |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ALL LBL Asparaginase Leukemia Childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hematologic Diseases |