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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia

Treatments: Drug: asparaginase Erwinia chrysanthemi

Study type: Interventional

Funder types: Industry

Identifiers

NCT01643408

100EUSA12

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open-Label Erwinaze

Experimental group

Treatment:

Drug: asparaginase Erwinia chrysanthemi