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Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224)

Phase 1
1 Year
21 Years
Not Enrolling
Relapsed Acute Lymphoblastic Leukemia, Allergy to PEG e.Coli Asparaginase, Allergy to Native e.Coli Asparaginase

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Trial Information

Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224)

Abbreviated List of Eligibility Criteria

Inclusion Criteria:

- Patients must have relapsed or refractory acute lymphoblastic leukemia with a M3
marrow (marrow blasts >25%) who have had no more than two prior therapeutic attempts.

- Patients must have a history of prior systemic allergic reaction to E. coli
asparaginase (native or pegylated), such as urticaria, wheezing, or anaphylaxis.

- Patients may be in first or second relapse and should not have received more than 2
induction attempts.

- Patients must have less than 350mg/m2 lifetime exposure of anthracycline

- Patients should not have received previous therapy using Erwinase.

Exclusion Criteria:

- Patients with prior history of Grade 2 or greater asparaginase-induced symptomatic
pancreatitis will be excluded.

- Patients with a prior history of asparaginase associated stroke are excluded.

- Patients will be excluded if their shortening fraction by echocardiogram is less than

- Patients who are pregnant or nursing an infant.


- Direct bilirubin > 1.5x the institutional upper limit of normal for age. A total
bilirubin result that is less than 1.5 times the institutional upper limit of normal
for age may be used for eligibility if a direct bilirubin result is not available.

- SGPT (ALT) > 4 x institutional upper limit of normal

- Amylase or Lipase > 2 x institutional upper limit of normal

- Serum creatinine is > the upper limit of normal for age at the institution's

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

Each dose level is evaluated

Safety Issue:


Principal Investigator

Heather Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hopital New York


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

June 2010

Related Keywords:

  • Relapsed Acute Lymphoblastic Leukemia
  • Allergy to PEG e.Coli Asparaginase
  • Allergy to Native e.Coli Asparaginase
  • Relapsed
  • Allergy
  • Erwinia
  • Acute
  • Lymphoblastic
  • Leukemia
  • Hypersensitivity
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Johns Hopkins University Baltimore, Maryland  21205
Stanford University Medical Center Stanford, California  94305-5408
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Childrens Hospital Los Angeles Los Angeles, California  90027
Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
City of Hope Duarte, California  91010
New York University Medical Center New York, New York  10016
Oregon Health and Science University Portland, Oregon  97201
Seattle Children's Hospital Seattle, Washington  98105
UCSF School of Medicine San Francisco, California  94143-0106
University of Miami Cancer Center Miami, Florida  33136
C.S. Mott Children's Hospital Ann Arbor, Michigan  48109-0914
Childrens Hospital & Clinics of Minnesota Minneapolis, Minnesota  55404-4597
Children's Hospital New York-Presbyterian New York, New York  10032
Miller Children's Hospital Long Beach, California  90806
Children's Memorial Chicago, Illinois  60614
Oakland Children's Hospital Oakland, California  
University of Minnesota Children's Hospital Minneapolis, Minnesota  
Nationwide Childrens Hospital Columbus, Ohio