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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
Both
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
chemotherapy.

- 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
30%.

- Patients who are pregnant or nursing an infant.

LABS

- 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
laboratory.

Type of Study:

Interventional

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:

Yes

Principal Investigator

Heather Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hopital New York

Authority:

United States: Food and Drug Administration

Study ID:

T2006-002

NCT ID:

NCT00928200

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

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Stanford University Medical CenterStanford, California  94305-5408
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Childrens Hospital Los AngelesLos Angeles, California  90027
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
City of HopeDuarte, California  91010
New York University Medical CenterNew York, New York  10016
Oregon Health and Science UniversityPortland, Oregon  97201
Seattle Children's HospitalSeattle, Washington  98105
UCSF School of MedicineSan Francisco, California  94143-0106
University of Miami Cancer CenterMiami, Florida  33136
C.S. Mott Children's HospitalAnn Arbor, Michigan  48109-0914
Childrens Hospital & Clinics of MinnesotaMinneapolis, Minnesota  55404-4597
Children's Hospital New York-PresbyterianNew York, New York  10032
Miller Children's HospitalLong Beach, California  90806
Children's MemorialChicago, Illinois  60614
Oakland Children's HospitalOakland, California  
University of Minnesota Children's HospitalMinneapolis, Minnesota  
Nationwide Childrens HospitalColumbus, Ohio