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Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) - NCT00928200-91010(Clinical Trial 299791)



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City:  Duarte
State:  
CA
Zip Code: 91010
Conditions: Relapsed Acute Lymphoblastic Leukemia - Allergy to PEG e.Coli Asparaginase - Allergy to Native e.Coli Asparaginase
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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