Clinical trial NCT01643408: A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Official title: Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Keywords: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Erwinaze
asparaginase
Eusa Pharma
Pharmacokinetic study
NSAA
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Two Day Nadir Serum Asparaginase Activity (NSAA) Level
timeFrame: 48 hours post-dose 5
Secondary outcomes:
measure: Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
timeFrame: 48 hours post-dose 5
measure: Three Day NSAA Level
timeFrame: 72 hours post-dose 6
measure: Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
timeFrame: 72 hours post-dose 6
measure: Nadir Serum Asparaginase Activity Over Time
timeFrame: 4 weeks to 30 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Orange County
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital
state: Colorado
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospital and Clinics of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ/Robert Wood Johnson
state: New Jersey
city: Bronx
country: United States
facility: Montifiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Sciences
state: Oregon
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Hamilton
country: Canada
facility: McMasters University Medical Center
state: Ontario
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
city: Saint Catherine
country: Canada
facility: Hospital St. Justine
state: Quebec
city: Sainte-Foy
country: Canada
facility: Quebec Children's Hospital
state: Quebec
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Lynda Vrooman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vrooman LM, Kirov II, Dreyer ZE, Kelly M, Hijiya N, Brown P, Drachtman RA, Messinger YH, Ritchey AK, Hale GA, Maloney K, Lu Y, Plourde PV, Silverman LB. Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2016 Feb;63(2):228-33. doi: 10.1002/pbc.25757. Epub 2015 Sep 16.