A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Jazz Pharmaceuticals30 enrolled

Overview

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

Interventions

asparaginase Erwinia chrysanthemiDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma, * Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis * Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma * Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol * Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol * Direct bilirubin less than or equal to Grade 2 * Amylase and lipase within normal limits (per institutional standards) * Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old. Exclusion Criteria: \-

Locations (22)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Two Day Nadir Serum Asparaginase Activity (NSAA) Level

To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

Time frame: 48 hours post-dose 5

Secondary Outcomes

Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours

To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

Time frame: 48 hours post-dose 5

Three Day NSAA Level

To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

Time frame: 72 hours post-dose 6

Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours

To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

Time frame: 72 hours post-dose 6

Nadir Serum Asparaginase Activity Over Time

To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).

Time frame: 4 weeks to 30 weeks

Data from ClinicalTrials.gov

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