Relapsed Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224)
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.
Significance
1. Substitution of Erwinase after E.coli asparaginase allergy has been standard practice
despite the paucity of evidence regarding its efficacy and uncertainty about dose.
Definition of an appropriate dose and schedule of Erwinase that provides reliable
asparagine depletion may be useful for patients with clinical allergy to E. coli
asparaginase, both in first remission or after relapse.
2. Patients in relapse may have a different level of asparagine synthesis than patients
maintaining remission and require different asparaginase dosing.5
3. Intravenous administration provides more rapid and predictable asparagine depletion with
less discomfort and danger of bleeding for often thrombocytopenic patients than
intramuscular administration.
4. Vincristine, doxorubicin, asparaginase, and dexamethasone with dexrazoxane is clinically
relevant for a population with first marrow relapse.
5. Vincristine, doxorubicin, asparaginase, and dexamethasone with dexrazoxane is clinically
relevant for a population with second marrow relapse, if the duration of CR2 > 18 months
year.
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