Niclosamide in Pediatric Patients With Relapsed and Refractory AML

Exclusion criteria

• . Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to control high WBC \> 50 x 103
• . Receiving any other investigational agents, including niclosamide.
• . Unresolved toxicities due to prior anticancer therapy, defined as not having resolved to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the inclusion/exclusion criteria with the exception of alopecia
• . Acute promyelocytic leukemia (French-American-British Class M3-AML)
• . Known active central nervous system (CNS) leukemia; subjects can enroll on study if CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the treating physician
• . Known congenital bleeding disorders, including but not limited to hemophilia
• . Known active uncontrolled systemic infection
• . Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, at the time of study entry