RecruitingPhase 1NCT05188170

Niclosamide in Pediatric Patients With Relapsed and Refractory AML

Phase 1 Study of Niclosamide (ANA001) in Pediatric Patients With Relapsed and Refractory AML


Sponsor

Stanford University

Enrollment

16 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing niclosamide — an antiparasitic drug being repurposed — in children and young adults with relapsed or treatment-resistant acute myeloid leukemia (AML) who have run out of other effective options. **You may be eligible if...** - You are between 2 and 30 years old with confirmed AML - Your cancer has come back or failed to respond to at least 2 rounds of intensive chemotherapy (or 4 rounds of non-intensive therapy) - You have not previously been treated with niclosamide - Your organ function is within acceptable ranges - You are able to take oral or tube-fed medication **You may NOT be eligible if...** - You have a specific leukemia subtype called acute promyelocytic leukemia (APL) - You have active brain (central nervous system) leukemia that is not being treated - You have a bleeding disorder or uncontrolled infection - You are currently pregnant or breastfeeding - You have active hepatitis C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiclosamide

Niclosamide will be administered orally for 14 days. Each dose will be followed by backbone chemotherapy


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT05188170


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