A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Completed
Jazz Pharmaceuticals
Phase 2
2012-11-01
This study will utilize Erwinaze via intravenous administration in patients between the ages
of 1 and 30 who have experienced an allergy to their frontline therapy. The study will
determine the proportion of patients with 2 day nadir serum asparaginase activity levels that
are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
Completed
Ashkan Emadi
Phase 1
2014-04-01
Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6
doses MWF over a period of 2 weeks to 9 patients (as described below and in the following
schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation
studies including fibrinogen will be measured and reviewed before each asparaginase dose.
Fibrinogen (
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
Recruiting
National Cancer Institute (NCI)
Phase 3
2015-11-23
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute
myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs
used in chemotherapy work in different ways to stop the growth of cancer cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Response-based chemotherapy separates patients into different risk groups and treats them
according to how they respond to the first course of treatment (Induction I). Response-based
treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in
younger patients with Down syndrome while reducing the side effects.
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