OncoMatch/Clinical Trials/NCT05188170
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Is NCT05188170 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05188170 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior niclosamide disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages