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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.


Phase 2
1 Year
30 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

Thank you

Trial Information

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.


Inclusion Criteria:



- Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,

- Ages >/= 1 and
- 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 byt he patient is greater than or equal to 18 years or by the
parent if the patient is younger than 18 years old.

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2 day NSAA level

Outcome Description:

To determine the proportion of patients with 2 day nadir serum asparaginase activity (NSAA) levels (48 hour levels taken after the 5th dose) that are > or = to 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

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Lynda Vrooman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

100EUSA12

NCT ID:

NCT01643408

Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Erwinaze
  • asparaginase
  • Eusa Pharma
  • Pharmacokinetic study
  • NSAA
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of WisconsinMilwaukee, Wisconsin  53201
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Columbia Presbyterian Medical CenterNew York, New York  10032
Texas Children's HospitalHouston, Texas  
Children's HospitalDenver, Colorado  80218
Children's Memorial HospitalChicago, Illinois  60614
Stanford Medical CenterStanford, California  94303
Children's Hospital of Los AngelesLos Angeles, California  90027
John HopkinsBaltimore, Maryland  21205
Children's Hospital and Clinics of MinnesotaMinneapolis, Minnesota  55404
University of MinnesotaMinneapolis, Michigan  55455
UMDNJ/Robert Wood JohnsonNew Brunswick, New Jersey  08903
Montifiore Medical CenterBronx, New York  10467
Oregon Health & SciencesPortland, Oregon  97239
Inova Fairfax Medical CenterFalls Church, Virginia  22042