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Asparaginase

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.

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

IM JZP-458

IV JZP-458 will be administered in Part B

IV JZP-458

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.

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

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

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.

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.

Blood samples were collected for serum asparaginase activity level determination.

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

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.

Children's Oncology Group (COG)

Jazz Pharmaceuticals

A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after the first dose of study treatment through the end of the study or any ongoing event that worsens in severity after the date of the first dose of study treatment through the end of the study.

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.

Part A: JZP-458 IM 25 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Part A: JZP-458 IM 37.5 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)

Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Demographic and baseline characteristics were assessed in the Safety Analysis Set.

Participants in this study received JZP-458 as part of a multi-agent chemotherapeutic regimen.

Clinical Trial Disclosure & Transparency

Response rates were assessed in the Efficacy Analysis Set in participants with available data.

Response Rate During the First Course of JZP-458 Administration

Safety events were assessed in the Safety Analysis Set.

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

Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set.

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

Last 48 hours

Last 72 hours

Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set in participants with available data.

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

Serum asparaginase activity levels were assessed in participants with available data in the Efficacy Analysis Set.

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

Overall confirmed ADA+

Overall ADA-

Immunogenicity was assessed in the Safety Analysis Set.

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

Part A

Part B

Lymphoma, Non-Hodgkin

Pegaspargase

pegcrisantaspase

Roman Skowronski, MD, PhD

The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).

The purpose of the study was to assess the response rate in children and young adults with ALL/LBL and hypersensitivity to pegaspargase defined as the proportion of subjects having a serum asparaginase activity (SAA) level of ≥ 0.1 IU/mL 14 days following the first IV pegcrisantaspase dose in Course 1. Also, to assess the safety of IV pegcrisantaspase therapy in children and young adults with ALL/LBL with hypersensitivity to pegaspargase.

A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)

IV administration of pegcrisantaspase in Course 1

Pegcrisantaspase

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Only 1 patient achieved the predefined SAA level above the 0.1 IU/mL therapeutic threshold 14 days following IV pegcrisantaspase dose in Course 1. Therefore, the corresponding PK parameters for repeated administration were not calculated.

Head of Clinical Development

Course 1; Day 0 (Screening)

Course 1; Day 1 (Pre-dose)

Course 1; Day 1 (1 hour post)

Course 1; Day 1 (3 hour post)

Course 1; Day 1 (5 hour post)

Course 1; Day 2 (Visit 2)

Course 1; Day 8 (Visit 3)

Course 1; Day 11 (Visit 4)

Course 1; Day 15 (Visit 5)

Only 1 of the first 4 patients dosed achieved the predefined serum asparaginase activity (SAA) level above the 0.1 IU/mL therapeutic threshold 14 days following the first IV pegcrisantaspase dose in Course 1 (Primary Objective of the study).

The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1

Not Applicable, as the study was terminated before this endpoint was analyzed.

The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.

The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)	NCT04145531	Acute Lymphobla... Lymphoblastic L...	IM JZP-458 IV JZP-458	-	Jazz Pharmaceuticals
A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)	NCT02257684	Acute Lymphobla... Lymphoblastic L...	pegcrisantaspas...	1 Year - 21 Years	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for lbl

Every month we try and update this database with for lbl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lbl

Every month we try and update this database with for lbl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lbl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.