Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)
Status:
Terminated
Trial end date:
2010-06-04
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium