At a glance
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A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)
In Brief
A Phase 3 clinical trial evaluating Asparaginase, Biospecimen Collection, and 20 other interventions for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 218 participants across 170 sites in 4 countries.
Detailed Summary
This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
Study Details
Timeline
Interventions
Given IV, IM, or PO
Undergo blood sample collection
Undergo bone marrow biopsy
Given IV
Given IV or IT
Given IV
Given IV or PO
Undergo ECHO
Given IV
Given IV or SC
Correlative studies
Given PO
Given IV
Given PO
Given IV, IT, or PO
Given IV
Undergo MUGA
Given IM
Correlative studies
Given PO
Given IT
Given IV