OncoMatch/Clinical Trials/NCT05188170
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Is NCT05188170 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Niclosamide for acute myeloid leukemia (aml).
Treatment: Niclosamide — Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Must have received: intensive chemotherapy
Disease relapse or the presence of refractory disease after 2 cycles of intensive chemotherapy
Must have received: non-intensive chemotherapy or hypomethylating agents
4 cycles of non-intensive chemotherapy or hypomethylating agents (HMAs)
Cannot have received: niclosamide (niclosamide)
No prior treatment with niclosamide
Lab requirements
Blood counts
Platelets 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet transfusion support is allowed)
Kidney function
Measured or calculated creatinine clearance 60 mL/min/1.73 m2 (by the Cockcroft-Gault method) within 14 days prior to treatment initiation
Liver function
Total bilirubin 2.0 x institutional upper limit of normal (ULN) within 14 days prior to treatment initiation (EXCEPTION: Subjects with Gilbert's syndrome may be included if the total bilirubin is 3.0 x ULN); SGOT (AST) 3.0 x ULN and SGPT (ALT) 3.0 x ULN within 14 days prior to treatment initiation
Platelets 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet transfusion support is allowed); Measured or calculated creatinine clearance 60 mL/min/1.73 m2 (by the Cockcroft-Gault method) within 14 days prior to treatment initiation; Total bilirubin 2.0 x institutional upper limit of normal (ULN) within 14 days prior to treatment initiation (EXCEPTION: Subjects with Gilbert's syndrome may be included if the total bilirubin is 3.0 x ULN); SGOT (AST) 3.0 x ULN and SGPT (ALT) 3.0 x ULN within 14 days prior to treatment initiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
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