CLINICAL TRIALS PROFILE FOR ERWINAZE
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All Clinical Trials for ERWINAZE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01643408 ↗ | 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. |
| NCT02150928 ↗ | An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) | Withdrawn | Jazz Pharmaceuticals | Phase 2 | 2014-05-01 | The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase. |
| NCT02283190 ↗ | 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 (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range. |
| NCT02521493 ↗ | 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. |
| NCT02521493 ↗ | Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome | Recruiting | Children's Oncology Group | 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. |
| NCT03914625 ↗ | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia | Recruiting | National Cancer Institute (NCI) | Phase 3 | 2019-06-28 | This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens. |
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