Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) - NCT00928200-55404 (Clinical Trial 299796)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy299796.aspx
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| City: |
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Minneapolis |
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State:
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MN |
| Zip Code: |
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55404 |
| Conditions: |
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Relapsed Acute Lymphoblastic Leukemia - Allergy to PEG e.Coli Asparaginase - Allergy to Native e.Coli Asparaginase |
| Purpose: |
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This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form
using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients
with relapsed ALL who have developed an allergy to the E. coli formulation. This study will
administer the drug intravenously instead of the usual intramuscular route. The dose of
Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first
or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Childrens Hospital & Clinics of Minnesota
Minneapolis, MN 55404
United States
Primary Contact:
Jeannette van der Giessen
Email: jvandergiessen@chla.usc.edu
Phone: 323-361-8725 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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